NCT02432274 · ADVERSE EVENTS

Adverse events

Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma · Source last updated 2023-07-11

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 the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Other-event reporting threshold: 0%

Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lenvatinib 5 mg/m^2 Eligible participants of age group 2 to \<6 years first underwent a 21-day run-in period with lenvatinib 5 mg/m\^2, once daily as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension) before receiving lenvatinib 11 mg/m\^2 or 14 mg/m\^2 in Cycle 1 of Cohort 1 (Single-agent Dose-finding).	0 / 2	2 / 2	0 / 2
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.	3 / 5	5 / 5	2 / 5
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.	7 / 11	11 / 11	7 / 11
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.	5 / 7	7 / 7	6 / 7
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.	1 / 1	1 / 1	0 / 1
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.	21 / 31	29 / 31	27 / 31
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.	7 / 11	11 / 11	10 / 11
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.	9 / 11	11 / 11	6 / 11
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.	16 / 20	20 / 20	14 / 20

Group identifiers: EG000: Lenvatinib 5 mg/m^2 · EG001: Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 · EG002: Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 · EG003: Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 · EG004: Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 · EG005: Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 · EG006: Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 · EG007: Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 · EG008: Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2

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
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
group Id
EG008
num Affected
1
num At Risk
20
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
2
num At Risk
31
num Events
2
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
11
num Events
1
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Enterocolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
2
num At Risk
11
num Events
3
group Id
EG008
num Affected
2
num At Risk
20
num Events
4
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
11
num Events
2
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Pneumonia

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
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
2
group Id
EG002
num Affected
2
num At Risk
11
num Events
2
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
5
num At Risk
31
num Events
7
group Id
EG006
num Affected
9
num At Risk
11
num Events
43
group Id
EG007
num Affected
7
num At Risk
11
num Events
29
group Id
EG008
num Affected
15
num At Risk
20
num Events
77
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
4
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
2
num At Risk
11
num Events
8
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
2
num At Risk
20
num Events
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
6
num At Risk
11
num Events
19
group Id
EG007
num Affected
6
num At Risk
11
num Events
25
group Id
EG008
num Affected
8
num At Risk
20
num Events
51
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Polycythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
3
num At Risk
31
num Events
7
group Id
EG006
num Affected
5
num At Risk
11
num Events
50
group Id
EG007
num Affected
4
num At Risk
11
num Events
54
group Id
EG008
num Affected
5
num At Risk
20
num Events
47
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
3
group Id
EG008
num Affected
2
num At Risk
20
num Events
2
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
group Id
EG001
num Affected
3
num At Risk
5
num Events
5
group Id
EG002
num Affected
6
num At Risk
11
num Events
10
group Id
EG003
num Affected
3
num At Risk
7
num Events
3
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
13
num At Risk
31
num Events
17
group Id
EG006
num Affected
6
num At Risk
11
num Events
7
group Id
EG007
num Affected
8
num At Risk
11
num Events
11
group Id
EG008
num Affected
6
num At Risk
20
num Events
8
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Eye ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Papilloedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
group Id
EG001
num Affected
2
num At Risk
5
num Events
3
group Id
EG002
num Affected
7
num At Risk
11
num Events
9
group Id
EG003
num Affected
2
num At Risk
7
num Events
6
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
9
num At Risk
31
num Events
27
group Id
EG006
num Affected
6
num At Risk
11
num Events
20
group Id
EG007
num Affected
6
num At Risk
11
num Events
18
group Id
EG008
num Affected
7
num At Risk
20
num Events
23
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
4
num At Risk
31
num Events
9
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
group Id
EG008
num Affected
4
num At Risk
20
num Events
8
term
Abdominal pain upper

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
2
description
Eligible participants of age group 2 to \<6 years first underwent a 21-day run-in period with lenvatinib 5 mg/m\^2, once daily as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension) before receiving lenvatinib 11 mg/m\^2 or 14 mg/m\^2 in Cycle 1 of Cohort 1 (Single-agent Dose-finding).
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Lenvatinib 5 mg/m^2
deaths Num Affected
2
deaths Num At Risk
5
description
Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
id
EG001
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
deaths Num Affected
7
deaths Num At Risk
11
description
Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
id
EG002
other Num Affected
11
other Num At Risk
11
serious Num Affected
7
serious Num At Risk
11
title
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
deaths Num Affected
6
deaths Num At Risk
7
description
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
id
EG003
other Num Affected
7
other Num At Risk
7
serious Num Affected
5
serious Num At Risk
7
title
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
id
EG004
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
deaths Num Affected
27
deaths Num At Risk
31
description
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
id
EG005
other Num Affected
29
other Num At Risk
31
serious Num Affected
21
serious Num At Risk
31
title
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
deaths Num Affected
10
deaths Num At Risk
11
description
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
id
EG006
other Num Affected
11
other Num At Risk
11
serious Num Affected
7
serious Num At Risk
11
title
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
deaths Num Affected
6
deaths Num At Risk
11
description
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
id
EG007
other Num Affected
11
other Num At Risk
11
serious Num Affected
9
serious Num At Risk
11
title
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
deaths Num Affected
14
deaths Num At Risk
20
description
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
id
EG008
other Num Affected
20
other Num At Risk
20
serious Num Affected
16
serious Num At Risk
20
title
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
2
group Id
EG002
num Affected
2
num At Risk
11
num Events
2
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
5
num At Risk
31
num Events
7
group Id
EG006
num Affected
9
num At Risk
11
num Events
43
group Id
EG007
num Affected
7
num At Risk
11
num Events
29
group Id
EG008
num Affected
15
num At Risk
20
num Events
77
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
4
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
2
num At Risk
11
num Events
8
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
2
num At Risk
20
num Events
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
6
num At Risk
11
num Events
19
group Id
EG007
num Affected
6
num At Risk
11
num Events
25
group Id
EG008
num Affected
8
num At Risk
20
num Events
51
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Polycythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
3
num At Risk
31
num Events
7
group Id
EG006
num Affected
5
num At Risk
11
num Events
50
group Id
EG007
num Affected
4
num At Risk
11
num Events
54
group Id
EG008
num Affected
5
num At Risk
20
num Events
47
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
3
group Id
EG008
num Affected
2
num At Risk
20
num Events
2
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
group Id
EG001
num Affected
3
num At Risk
5
num Events
5
group Id
EG002
num Affected
6
num At Risk
11
num Events
10
group Id
EG003
num Affected
3
num At Risk
7
num Events
3
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
13
num At Risk
31
num Events
17
group Id
EG006
num Affected
6
num At Risk
11
num Events
7
group Id
EG007
num Affected
8
num At Risk
11
num Events
11
group Id
EG008
num Affected
6
num At Risk
20
num Events
8
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Eye ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Papilloedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
group Id
EG001
num Affected
2
num At Risk
5
num Events
3
group Id
EG002
num Affected
7
num At Risk
11
num Events
9
group Id
EG003
num Affected
2
num At Risk
7
num Events
6
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
9
num At Risk
31
num Events
27
group Id
EG006
num Affected
6
num At Risk
11
num Events
20
group Id
EG007
num Affected
6
num At Risk
11
num Events
18
group Id
EG008
num Affected
7
num At Risk
20
num Events
23
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
4
num At Risk
31
num Events
9
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
group Id
EG008
num Affected
4
num At Risk
20
num Events
8
term
Abdominal pain upper

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
group Id
EG008
num Affected
1
num At Risk
20
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
2
num At Risk
31
num Events
2
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
11
num Events
1
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Enterocolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
2
num At Risk
11
num Events
3
group Id
EG008
num Affected
2
num At Risk
20
num Events
4
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
11
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
11
num Events
2
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
term
Pneumonia

time Frame

From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)

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

Preserved source evidence · Not medical advice