NCT01136733 · ADVERSE EVENTS

Adverse events

A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment · Source last updated 2019-02-27

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: Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.
Other-event reporting threshold: 5%

Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2. If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.	6 / 7	7 / 7	6 / 7
Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.	8 / 11	11 / 11	9 / 11
Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.	0 / 2	2 / 2	0 / 2
Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus The DLT was achieved and no participants were enrolled into this cohort.	0 / 0	0 / 0	0 / 0
Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.	30 / 51	51 / 51	43 / 51
Phase 2 (Arm B): 24 mg Lenvatinib Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.	28 / 52	51 / 52	40 / 52
Phase 2 (Arm C): 10 mg Everolimus Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4 week) cycles.	21 / 50	50 / 50	45 / 50

Group identifiers: EG000: Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus · EG001: Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus · EG002: Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus · EG003: Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus · EG004: Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus · EG005: Phase 2 (Arm B): 24 mg Lenvatinib · EG006: Phase 2 (Arm C): 10 mg Everolimus

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
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
1
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
2
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
2
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
1
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
2
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
General Physical Health Deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
1
num At Risk
50
term
Non-Cardiac Chest Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Cholangitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Lung Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
1
num At Risk
50
term
Ejection Fraction Decreased

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 19.1
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
7
num At Risk
51
group Id
EG005
num Affected
3
num At Risk
52
group Id
EG006
num Affected
11
num At Risk
50
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Haemorrhagic Disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
5
num At Risk
51
group Id
EG005
num Affected
1
num At Risk
52
group Id
EG006
num Affected
4
num At Risk
50
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Angina Pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Aortic Valve Incompetence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Coronary Artery Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
1
num At Risk
50
term
Coronary Artery Occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Mitral Valve Incompetence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
2
num At Risk
50
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
2
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Tachycardia

Complete source fields

description

event Groups

deaths Num Affected
6
deaths Num At Risk
7
description
Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2. If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.
id
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
6
serious Num At Risk
7
title
Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus
deaths Num Affected
9
deaths Num At Risk
11
description
Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
id
EG001
other Num Affected
11
other Num At Risk
11
serious Num Affected
8
serious Num At Risk
11
title
Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus
deaths Num Affected
0
deaths Num At Risk
2
description
Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
id
EG002
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus
deaths Num Affected
0
deaths Num At Risk
0
description
The DLT was achieved and no participants were enrolled into this cohort.
id
EG003
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus
deaths Num Affected
43
deaths Num At Risk
51
description
Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
id
EG004
other Num Affected
51
other Num At Risk
51
serious Num Affected
30
serious Num At Risk
51
title
Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus
deaths Num Affected
40
deaths Num At Risk
52
description
Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
id
EG005
other Num Affected
51
other Num At Risk
52
serious Num Affected
28
serious Num At Risk
52
title
Phase 2 (Arm B): 24 mg Lenvatinib
deaths Num Affected
45
deaths Num At Risk
50
description
Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4 week) cycles.
id
EG006
other Num Affected
50
other Num At Risk
50
serious Num Affected
21
serious Num At Risk
50
title
Phase 2 (Arm C): 10 mg Everolimus

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
7
num At Risk
51
group Id
EG005
num Affected
3
num At Risk
52
group Id
EG006
num Affected
11
num At Risk
50
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Haemorrhagic Disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
5
num At Risk
51
group Id
EG005
num Affected
1
num At Risk
52
group Id
EG006
num Affected
4
num At Risk
50
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Angina Pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Aortic Valve Incompetence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Coronary Artery Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
1
num At Risk
50
term
Coronary Artery Occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Mitral Valve Incompetence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
2
num At Risk
50
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
2
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Tachycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
1
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
2
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
2
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
1
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
2
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
General Physical Health Deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
1
num At Risk
50
term
Non-Cardiac Chest Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
1
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Cholangitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
0
num At Risk
50
term
Lung Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
0
group Id
EG004
num Affected
0
num At Risk
51
group Id
EG005
num Affected
0
num At Risk
52
group Id
EG006
num Affected
1
num At Risk
50
term
Ejection Fraction Decreased

time Frame

Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.

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Preserved source evidence · Not medical advice