NCT02452424 · ADVERSE EVENTS

Adverse events

A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors · Source last updated 2020-03-05

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: Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Other-event reporting threshold: 5%

Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Escalation: 400 mg/Day Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).	2 / 4	4 / 4	2 / 4
Dose Escalation: 600 mg/Day Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).	1 / 3	3 / 3	2 / 3
Dose Escalation: 600 mg/Day (Liver Metastases Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).	3 / 7	7 / 7	2 / 7
Dose Escalation: 600 mg/Day (no Liver Metastases) Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).	3 / 9	9 / 9	6 / 9
Dose Escalation: 800 mg/Day (Liver Metastases) Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).	2 / 4	4 / 4	2 / 4
Dose Escalation: 800 mg/Day (no Liver Metastases) Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).	3 / 6	6 / 6	0 / 6
Dose Expansion: Melanoma Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).	3 / 13	12 / 13	5 / 13
Dose Expansion: NSCLC Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).	3 / 8	8 / 8	1 / 8
Dose Expansion: Ovarian Cancer Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).	5 / 15	15 / 15	3 / 15
Dose Expansion: SCCHN Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).	1 / 3	3 / 3	1 / 3
Dose Expansion: GIST Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).	0 / 6	6 / 6	0 / 6

Group identifiers: EG000: Dose Escalation: 400 mg/Day · EG001: Dose Escalation: 600 mg/Day · EG002: Dose Escalation: 600 mg/Day (Liver Metastases · EG003: Dose Escalation: 600 mg/Day (no Liver Metastases) · EG004: Dose Escalation: 800 mg/Day (Liver Metastases) · EG005: Dose Escalation: 800 mg/Day (no Liver Metastases) · EG006: Dose Expansion: Melanoma · EG007: Dose Expansion: NSCLC · EG008: Dose Expansion: Ovarian Cancer · EG009: Dose Expansion: SCCHN · EG010: Dose Expansion: GIST

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 (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Faecaloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Obstruction gastric
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
2
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Generalised oedema

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 (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
5
num At Risk
13
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
6
num At Risk
15
group Id
EG009
num Affected
2
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
term
Anemia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
15
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Leukopenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
13
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Lymphadenopathy (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Lymphopenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
6
term
Neutropenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Pancytopenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Splenic infarction (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
2
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Thrombocytopenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Atrial fibrillation (All grades)

Complete source fields

description

Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.

event Groups

deaths Num Affected
2
deaths Num At Risk
4
description
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Dose Escalation: 400 mg/Day
deaths Num Affected
2
deaths Num At Risk
3
description
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Dose Escalation: 600 mg/Day
deaths Num Affected
2
deaths Num At Risk
7
description
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Dose Escalation: 600 mg/Day (Liver Metastases
deaths Num Affected
6
deaths Num At Risk
9
description
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
id
EG003
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
Dose Escalation: 600 mg/Day (no Liver Metastases)
deaths Num Affected
2
deaths Num At Risk
4
description
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
id
EG004
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Dose Escalation: 800 mg/Day (Liver Metastases)
deaths Num Affected
0
deaths Num At Risk
6
description
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Dose Escalation: 800 mg/Day (no Liver Metastases)
deaths Num Affected
5
deaths Num At Risk
13
description
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
id
EG006
other Num Affected
12
other Num At Risk
13
serious Num Affected
3
serious Num At Risk
13
title
Dose Expansion: Melanoma
deaths Num Affected
1
deaths Num At Risk
8
description
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
id
EG007
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
Dose Expansion: NSCLC
deaths Num Affected
3
deaths Num At Risk
15
description
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
id
EG008
other Num Affected
15
other Num At Risk
15
serious Num Affected
5
serious Num At Risk
15
title
Dose Expansion: Ovarian Cancer
deaths Num Affected
1
deaths Num At Risk
3
description
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
id
EG009
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Dose Expansion: SCCHN
deaths Num Affected
0
deaths Num At Risk
6
description
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
id
EG010
other Num Affected
6
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Dose Expansion: GIST

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
5
num At Risk
13
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
6
num At Risk
15
group Id
EG009
num Affected
2
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
term
Anemia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
15
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Leukopenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
13
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Lymphadenopathy (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Lymphopenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
6
term
Neutropenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Pancytopenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Splenic infarction (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
2
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Thrombocytopenia (All grades)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Atrial fibrillation (All grades)

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Faecaloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Obstruction gastric
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
2
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
15
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
term
Generalised oedema

time Frame

Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)

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

Preserved source evidence · Not medical advice