NCT01177397 · ADVERSE EVENTS

Adverse events

Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma · Source last updated 2022-12-13

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: All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
Other-event reporting threshold: 5%

Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A: CC-223 7.5 mg Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.	0 / 1	1 / 1	0 / 1
Part A: CC-223 15 mg Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.	0 / 2	2 / 2	0 / 2
Part A: CC-223 30 mg Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.	4 / 9	8 / 9	2 / 9
Part A: CC-223 45 mg Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.	4 / 9	9 / 9	3 / 9
Part A: CC-223 60 mg Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.	2 / 7	7 / 7	1 / 7
Part B: Non-small Cell Lung Cancer (NSCLC) Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.	15 / 26	26 / 26	10 / 26
Part B: Glioblastoma Multiforme (GBM) Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.	6 / 13	13 / 13	3 / 13
Part B: Hepatocellular Carcinoma (HCC) Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.	29 / 53	53 / 53	24 / 53
Part B: Neuroendocrine Tumor (NET) Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.	23 / 47	47 / 47	2 / 47
Part B: Diffuse Large B-cell Lymphoma (DLBCL) Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.	17 / 28	28 / 28	5 / 28
Part B: Multiple Myeloma (MM) Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.	6 / 14	14 / 14	2 / 14
Part B: Hormone Receptor Positive Breast Cancer (HRPBC) Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.	11 / 17	17 / 17	4 / 17

Group identifiers: EG000: Part A: CC-223 7.5 mg · EG001: Part A: CC-223 15 mg · EG002: Part A: CC-223 30 mg · EG003: Part A: CC-223 45 mg · EG004: Part A: CC-223 60 mg · EG005: Part B: Non-small Cell Lung Cancer (NSCLC) · EG006: Part B: Glioblastoma Multiforme (GBM) · EG007: Part B: Hepatocellular Carcinoma (HCC) · EG008: Part B: Neuroendocrine Tumor (NET) · EG009: Part B: Diffuse Large B-cell Lymphoma (DLBCL) · EG010: Part B: Multiple Myeloma (MM) · EG011: Part B: Hormone Receptor Positive Breast Cancer (HRPBC)

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 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
1
num At Risk
28
num Events
1
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
1
num At Risk
47
num Events
1
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
17
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
group Id
EG011
num Affected
1
num At Risk
17
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
1
num At Risk
47
num Events
1
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Atrial thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
1
num At Risk
28
num Events
1
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
26
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
2
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
26
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
2
num At Risk
47
num Events
2
group Id
EG009
num Affected
2
num At Risk
28
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
17
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Aphthous ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
26
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
1
num At Risk
47
num Events
1
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
2
num At Risk
17
num Events
2
term
Ascites

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 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
8
num At Risk
26
num Events
12
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
5
num At Risk
53
num Events
5
group Id
EG008
num Affected
3
num At Risk
47
num Events
3
group Id
EG009
num Affected
8
num At Risk
28
num Events
9
group Id
EG010
num Affected
7
num At Risk
14
num Events
24
group Id
EG011
num Affected
5
num At Risk
17
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
3
num At Risk
53
num Events
3
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
17
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
3
num At Risk
13
num Events
6
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
2
num At Risk
13
num Events
4
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
2
num At Risk
17
num Events
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
3
num At Risk
13
num Events
5
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
3
num At Risk
47
num Events
8
group Id
EG009
num Affected
6
num At Risk
28
num Events
12
group Id
EG010
num Affected
4
num At Risk
14
num Events
18
group Id
EG011
num Affected
3
num At Risk
17
num Events
9
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
group Id
EG003
num Affected
2
num At Risk
9
num Events
3
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
4
num At Risk
26
num Events
7
group Id
EG006
num Affected
2
num At Risk
13
num Events
2
group Id
EG007
num Affected
16
num At Risk
53
num Events
30
group Id
EG008
num Affected
5
num At Risk
47
num Events
14
group Id
EG009
num Affected
11
num At Risk
28
num Events
23
group Id
EG010
num Affected
7
num At Risk
14
num Events
29
group Id
EG011
num Affected
6
num At Risk
17
num Events
9
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
2
num At Risk
26
num Events
2
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
2
num At Risk
26
num Events
4
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
3
num At Risk
47
num Events
4
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Palpitations

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Part A: CC-223 7.5 mg
deaths Num Affected
0
deaths Num At Risk
2
description
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG001
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Part A: CC-223 15 mg
deaths Num Affected
2
deaths Num At Risk
9
description
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG002
other Num Affected
8
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
Part A: CC-223 30 mg
deaths Num Affected
3
deaths Num At Risk
9
description
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG003
other Num Affected
9
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
Part A: CC-223 45 mg
deaths Num Affected
1
deaths Num At Risk
7
description
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG004
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Part A: CC-223 60 mg
deaths Num Affected
10
deaths Num At Risk
26
description
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG005
other Num Affected
26
other Num At Risk
26
serious Num Affected
15
serious Num At Risk
26
title
Part B: Non-small Cell Lung Cancer (NSCLC)
deaths Num Affected
3
deaths Num At Risk
13
description
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG006
other Num Affected
13
other Num At Risk
13
serious Num Affected
6
serious Num At Risk
13
title
Part B: Glioblastoma Multiforme (GBM)
deaths Num Affected
24
deaths Num At Risk
53
description
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG007
other Num Affected
53
other Num At Risk
53
serious Num Affected
29
serious Num At Risk
53
title
Part B: Hepatocellular Carcinoma (HCC)
deaths Num Affected
2
deaths Num At Risk
47
description
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG008
other Num Affected
47
other Num At Risk
47
serious Num Affected
23
serious Num At Risk
47
title
Part B: Neuroendocrine Tumor (NET)
deaths Num Affected
5
deaths Num At Risk
28
description
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG009
other Num Affected
28
other Num At Risk
28
serious Num Affected
17
serious Num At Risk
28
title
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
deaths Num Affected
2
deaths Num At Risk
14
description
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG010
other Num Affected
14
other Num At Risk
14
serious Num Affected
6
serious Num At Risk
14
title
Part B: Multiple Myeloma (MM)
deaths Num Affected
4
deaths Num At Risk
17
description
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
id
EG011
other Num Affected
17
other Num At Risk
17
serious Num Affected
11
serious Num At Risk
17
title
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
8
num At Risk
26
num Events
12
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
5
num At Risk
53
num Events
5
group Id
EG008
num Affected
3
num At Risk
47
num Events
3
group Id
EG009
num Affected
8
num At Risk
28
num Events
9
group Id
EG010
num Affected
7
num At Risk
14
num Events
24
group Id
EG011
num Affected
5
num At Risk
17
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
3
num At Risk
53
num Events
3
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
17
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
3
num At Risk
13
num Events
6
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
2
num At Risk
13
num Events
4
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
2
num At Risk
17
num Events
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
3
num At Risk
13
num Events
5
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
3
num At Risk
47
num Events
8
group Id
EG009
num Affected
6
num At Risk
28
num Events
12
group Id
EG010
num Affected
4
num At Risk
14
num Events
18
group Id
EG011
num Affected
3
num At Risk
17
num Events
9
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
group Id
EG003
num Affected
2
num At Risk
9
num Events
3
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
4
num At Risk
26
num Events
7
group Id
EG006
num Affected
2
num At Risk
13
num Events
2
group Id
EG007
num Affected
16
num At Risk
53
num Events
30
group Id
EG008
num Affected
5
num At Risk
47
num Events
14
group Id
EG009
num Affected
11
num At Risk
28
num Events
23
group Id
EG010
num Affected
7
num At Risk
14
num Events
29
group Id
EG011
num Affected
6
num At Risk
17
num Events
9
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
2
num At Risk
26
num Events
2
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
2
num At Risk
26
num Events
4
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
3
num At Risk
47
num Events
4
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Palpitations

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
1
num At Risk
28
num Events
1
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
1
num At Risk
47
num Events
1
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
17
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
group Id
EG011
num Affected
1
num At Risk
17
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
1
num At Risk
47
num Events
1
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Atrial thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
1
num At Risk
28
num Events
1
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
26
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
2
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
26
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
2
num At Risk
47
num Events
2
group Id
EG009
num Affected
2
num At Risk
28
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
17
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
26
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
53
num Events
0
group Id
EG008
num Affected
0
num At Risk
47
num Events
0
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
group Id
EG011
num Affected
0
num At Risk
17
num Events
0
term
Aphthous ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
group Id
EG003
num Affected
0
num At Risk
9
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
26
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
53
num Events
1
group Id
EG008
num Affected
1
num At Risk
47
num Events
1
group Id
EG009
num Affected
0
num At Risk
28
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
2
num At Risk
17
num Events
2
term
Ascites

time Frame

All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).

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

Preserved source evidence · Not medical advice