NCT05011058 · ADVERSE EVENTS

Adverse events

An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas · Source last updated 2025-07-28

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: Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Diffuse Large B-Cell Lymphoma Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	3 / 9	9 / 9	3 / 9
Extranodal Natural Killer/T-Cell Lymphoma Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	7 / 11	10 / 11	9 / 11
Peripheral T-Cell Lymphoma (Combination Therapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	9 / 38	32 / 38	9 / 38
Peripheral T-Cell Lymphoma (Monotherapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	5 / 10	10 / 10	4 / 10
Peripheral T-Cell Lymphoma (Crossover) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort	3 / 5	5 / 5	2 / 5
Hodgkin Lymphoma Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	2 / 8	7 / 8	3 / 8
Post-Transplant Lymphoproliferative Disorders Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	3 / 3	3 / 3	1 / 3
Human Immunodeficiency Virus-Associated Lymphomas Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	2 / 3	3 / 3	1 / 3
Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	10 / 20	17 / 20	8 / 20

Group identifiers: EG000: Diffuse Large B-Cell Lymphoma · EG001: Extranodal Natural Killer/T-Cell Lymphoma · EG002: Peripheral T-Cell Lymphoma (Combination Therapy) · EG003: Peripheral T-Cell Lymphoma (Monotherapy) · EG004: Peripheral T-Cell Lymphoma (Crossover) · EG005: Hodgkin Lymphoma · EG006: Post-Transplant Lymphoproliferative Disorders · EG007: Human Immunodeficiency Virus-Associated Lymphomas · EG008: Other EBV-Positive Lymphomas

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
4
num At Risk
20
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Abdominal infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
Escherichia infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
H1N1 influenza
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Influenza
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Lymph gland infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Pharyngitis

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
7
num At Risk
38
group Id
EG003
num Affected
5
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
5
group Id
EG005
num Affected
4
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
2
num At Risk
3
group Id
EG008
num Affected
7
num At Risk
20
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
7
num At Risk
11
group Id
EG002
num Affected
12
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
4
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
5
num At Risk
20
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
9
num At Risk
38
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
7
num At Risk
20
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
8
num At Risk
38
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
8
group Id
EG006
num Affected
2
num At Risk
3
group Id
EG007
num Affected
2
num At Risk
3
group Id
EG008
num Affected
7
num At Risk
20
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
6
num At Risk
11
group Id
EG002
num Affected
12
num At Risk
38
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
4
num At Risk
20
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
9
num At Risk
38
group Id
EG003
num Affected
5
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
5
num At Risk
20
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
8
num At Risk
38
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
20
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
6
num At Risk
38
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
20
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
5
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
2
num At Risk
20
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
4
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
20
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
4
num At Risk
38
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
3
num At Risk
11
group Id
EG002
num Affected
5
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
2
num At Risk
20
term
Dyspnoea

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
9
description
Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
id
EG000
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
Diffuse Large B-Cell Lymphoma
deaths Num Affected
9
deaths Num At Risk
11
description
Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
id
EG001
other Num Affected
10
other Num At Risk
11
serious Num Affected
7
serious Num At Risk
11
title
Extranodal Natural Killer/T-Cell Lymphoma
deaths Num Affected
9
deaths Num At Risk
38
description
Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
id
EG002
other Num Affected
32
other Num At Risk
38
serious Num Affected
9
serious Num At Risk
38
title
Peripheral T-Cell Lymphoma (Combination Therapy)
deaths Num Affected
4
deaths Num At Risk
10
description
Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Peripheral T-Cell Lymphoma (Monotherapy)
deaths Num Affected
2
deaths Num At Risk
5
description
Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort
id
EG004
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Peripheral T-Cell Lymphoma (Crossover)
deaths Num Affected
3
deaths Num At Risk
8
description
Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
id
EG005
other Num Affected
7
other Num At Risk
8
serious Num Affected
2
serious Num At Risk
8
title
Hodgkin Lymphoma
deaths Num Affected
1
deaths Num At Risk
3
description
Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
id
EG006
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Post-Transplant Lymphoproliferative Disorders
deaths Num Affected
1
deaths Num At Risk
3
description
Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Human Immunodeficiency Virus-Associated Lymphomas
deaths Num Affected
8
deaths Num At Risk
20
description
Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
id
EG008
other Num Affected
17
other Num At Risk
20
serious Num Affected
10
serious Num At Risk
20
title
Other EBV-Positive Lymphomas

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
7
num At Risk
38
group Id
EG003
num Affected
5
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
5
group Id
EG005
num Affected
4
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
2
num At Risk
3
group Id
EG008
num Affected
7
num At Risk
20
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
7
num At Risk
11
group Id
EG002
num Affected
12
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
4
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
5
num At Risk
20
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
9
num At Risk
38
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
7
num At Risk
20
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
8
num At Risk
38
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
8
group Id
EG006
num Affected
2
num At Risk
3
group Id
EG007
num Affected
2
num At Risk
3
group Id
EG008
num Affected
7
num At Risk
20
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
6
num At Risk
11
group Id
EG002
num Affected
12
num At Risk
38
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
4
num At Risk
20
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
9
num At Risk
38
group Id
EG003
num Affected
5
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
5
num At Risk
20
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
8
num At Risk
38
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
20
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
6
num At Risk
38
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
20
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
5
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
2
num At Risk
20
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
4
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
20
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
4
num At Risk
38
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
3
num At Risk
11
group Id
EG002
num Affected
5
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
2
num At Risk
20
term
Dyspnoea

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
4
num At Risk
20
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Abdominal infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
Escherichia infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
20
term
H1N1 influenza
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Influenza
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Lymph gland infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
38
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
20
term
Pharyngitis

time Frame

Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events

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

Preserved source evidence · Not medical advice