NCT03245151 · ADVERSE EVENTS

Adverse events

Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors · Source last updated 2023-08-30

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 date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months)
Other-event reporting threshold: 5%

SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	2 / 5	5 / 5	4 / 5
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	12 / 18	18 / 18	14 / 18
Phase 2: Cohort 1, Ewing Sarcoma Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	6 / 10	10 / 10	9 / 10
Phase 2: Cohort 2, Rhabdomyosarcoma Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	8 / 20	19 / 20	17 / 20
Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	8 / 11	11 / 11	8 / 11

Group identifiers: EG000: Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 · EG001: Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 · EG002: Phase 2: Cohort 1, Ewing Sarcoma · EG003: Phase 2: Cohort 2, Rhabdomyosarcoma · EG004: Phase 2: Cohort 3, HGG

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 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
2
num At Risk
18
num Events
2
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Face oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
3
num At Risk
10
num Events
3
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Pneumonia aspiration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
2
num At Risk
20
num Events
2
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Upper respiratory tract infections

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 25.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
6
group Id
EG001
num Affected
6
num At Risk
18
num Events
16
group Id
EG002
num Affected
5
num At Risk
10
num Events
17
group Id
EG003
num Affected
7
num At Risk
20
num Events
10
group Id
EG004
num Affected
1
num At Risk
11
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
3
num At Risk
20
num Events
3
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
6
group Id
EG001
num Affected
4
num At Risk
18
num Events
5
group Id
EG002
num Affected
1
num At Risk
10
num Events
2
group Id
EG003
num Affected
3
num At Risk
20
num Events
5
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Wolff-Parkinson-White syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
2
num At Risk
18
num Events
2
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
3
group Id
EG001
num Affected
10
num At Risk
18
num Events
13
group Id
EG002
num Affected
2
num At Risk
10
num Events
3
group Id
EG003
num Affected
8
num At Risk
20
num Events
14
group Id
EG004
num Affected
6
num At Risk
11
num Events
7
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Hyperparathyroidism

Complete source fields

description

SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).

event Groups

deaths Num Affected
4
deaths Num At Risk
5
description
Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2
deaths Num Affected
14
deaths Num At Risk
18
description
Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
id
EG001
other Num Affected
18
other Num At Risk
18
serious Num Affected
12
serious Num At Risk
18
title
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2
deaths Num Affected
9
deaths Num At Risk
10
description
Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
id
EG002
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
Phase 2: Cohort 1, Ewing Sarcoma
deaths Num Affected
17
deaths Num At Risk
20
description
Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
id
EG003
other Num Affected
19
other Num At Risk
20
serious Num Affected
8
serious Num At Risk
20
title
Phase 2: Cohort 2, Rhabdomyosarcoma
deaths Num Affected
8
deaths Num At Risk
11
description
Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
id
EG004
other Num Affected
11
other Num At Risk
11
serious Num Affected
8
serious Num At Risk
11
title
Phase 2: Cohort 3, HGG

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
6
group Id
EG001
num Affected
6
num At Risk
18
num Events
16
group Id
EG002
num Affected
5
num At Risk
10
num Events
17
group Id
EG003
num Affected
7
num At Risk
20
num Events
10
group Id
EG004
num Affected
1
num At Risk
11
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
3
num At Risk
20
num Events
3
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
6
group Id
EG001
num Affected
4
num At Risk
18
num Events
5
group Id
EG002
num Affected
1
num At Risk
10
num Events
2
group Id
EG003
num Affected
3
num At Risk
20
num Events
5
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Wolff-Parkinson-White syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
2
num At Risk
18
num Events
2
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
3
group Id
EG001
num Affected
10
num At Risk
18
num Events
13
group Id
EG002
num Affected
2
num At Risk
10
num Events
3
group Id
EG003
num Affected
8
num At Risk
20
num Events
14
group Id
EG004
num Affected
6
num At Risk
11
num Events
7
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Hyperparathyroidism

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
2
num At Risk
18
num Events
2
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Face oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
3
num At Risk
10
num Events
3
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Pneumonia aspiration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
2
num At Risk
20
num Events
2
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
term
Upper respiratory tract infections

time Frame

From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice