NCT01072175 · ADVERSE EVENTS

Adverse events

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05

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 Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A: Dabrafenib 75 mg + Trametinib 2 mg Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).	5 / 8	8 / 8	2 / 8
Part B: Dabrafenib 75 mg + Trametinib 1 mg Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.	1 / 6	6 / 6	0 / 6
Part B: Dabrafenib 150 mg + Trametinib 1 mg Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.	15 / 23	23 / 23	1 / 23
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.	14 / 27	27 / 27	6 / 27
Part B: Dabrafenib 150 mg + Trametinib 2 mg Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.	55 / 94	91 / 94	12 / 94
Part C (Randomized): Dabrafenib 150 mg Participants received dabrafenib 150 mg gelatin capsules BID.	15 / 53	53 / 53	1 / 53
Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.	24 / 54	53 / 54	4 / 54
Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.	39 / 55	55 / 55	7 / 55
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.	24 / 45	44 / 45	7 / 45
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.	8 / 15	15 / 15	1 / 15
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.	11 / 15	15 / 15	4 / 15
Part D: Dabrafenib 75 mg + Trametinib 2 mg Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.	29 / 41	41 / 41	7 / 41
Part D: Dabrafenib 150 mg + Trametinib 2 mg Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.	30 / 39	37 / 39	2 / 39

Group identifiers: EG000: Part A: Dabrafenib 75 mg + Trametinib 2 mg · EG001: Part B: Dabrafenib 75 mg + Trametinib 1 mg · EG002: Part B: Dabrafenib 150 mg + Trametinib 1 mg · EG003: Part B: Dabrafenib 150 mg + Trametinib 1.5 mg · EG004: Part B: Dabrafenib 150 mg + Trametinib 2 mg · EG005: Part C (Randomized): Dabrafenib 150 mg · EG006: Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg · EG007: Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg · EG008: Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg · EG009: Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg · EG010: Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg · EG011: Part D: Dabrafenib 75 mg + Trametinib 2 mg · EG012: Part D: Dabrafenib 150 mg + Trametinib 2 mg

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 (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
3
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
2
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Immune thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
2
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
2
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Atrial thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Cardiogenic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Left ventricular dysfunction

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 (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
4
num At Risk
23
group Id
EG003
num Affected
3
num At Risk
27
group Id
EG004
num Affected
21
num At Risk
94
group Id
EG005
num Affected
3
num At Risk
53
group Id
EG006
num Affected
10
num At Risk
54
group Id
EG007
num Affected
12
num At Risk
55
group Id
EG008
num Affected
9
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
6
num At Risk
15
group Id
EG011
num Affected
8
num At Risk
41
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
5
num At Risk
23
group Id
EG003
num Affected
3
num At Risk
27
group Id
EG004
num Affected
8
num At Risk
94
group Id
EG005
num Affected
2
num At Risk
53
group Id
EG006
num Affected
2
num At Risk
54
group Id
EG007
num Affected
2
num At Risk
55
group Id
EG008
num Affected
3
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
1
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
3
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
3
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
2
num At Risk
41
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
3
num At Risk
23
group Id
EG003
num Affected
6
num At Risk
27
group Id
EG004
num Affected
11
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
8
num At Risk
54
group Id
EG007
num Affected
4
num At Risk
55
group Id
EG008
num Affected
2
num At Risk
45
group Id
EG009
num Affected
1
num At Risk
15
group Id
EG010
num Affected
2
num At Risk
15
group Id
EG011
num Affected
3
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
3
num At Risk
27
group Id
EG004
num Affected
10
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
2
num At Risk
54
group Id
EG007
num Affected
3
num At Risk
55
group Id
EG008
num Affected
1
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
1
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Intracardiac mass
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
3
num At Risk
53
group Id
EG006
num Affected
3
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
2
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
3
num At Risk
41
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
2
num At Risk
27
group Id
EG004
num Affected
7
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
3
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
2
num At Risk
41
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Dermoid cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
3
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Ear congestion

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
8
description
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
5
serious Num At Risk
8
title
Part A: Dabrafenib 75 mg + Trametinib 2 mg
deaths Num Affected
0
deaths Num At Risk
6
description
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Part B: Dabrafenib 75 mg + Trametinib 1 mg
deaths Num Affected
1
deaths Num At Risk
23
description
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
id
EG002
other Num Affected
23
other Num At Risk
23
serious Num Affected
15
serious Num At Risk
23
title
Part B: Dabrafenib 150 mg + Trametinib 1 mg
deaths Num Affected
6
deaths Num At Risk
27
description
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
id
EG003
other Num Affected
27
other Num At Risk
27
serious Num Affected
14
serious Num At Risk
27
title
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
deaths Num Affected
12
deaths Num At Risk
94
description
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
id
EG004
other Num Affected
91
other Num At Risk
94
serious Num Affected
55
serious Num At Risk
94
title
Part B: Dabrafenib 150 mg + Trametinib 2 mg
deaths Num Affected
1
deaths Num At Risk
53
description
Participants received dabrafenib 150 mg gelatin capsules BID.
id
EG005
other Num Affected
53
other Num At Risk
53
serious Num Affected
15
serious Num At Risk
53
title
Part C (Randomized): Dabrafenib 150 mg
deaths Num Affected
4
deaths Num At Risk
54
description
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
id
EG006
other Num Affected
53
other Num At Risk
54
serious Num Affected
24
serious Num At Risk
54
title
Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg
deaths Num Affected
7
deaths Num At Risk
55
description
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
id
EG007
other Num Affected
55
other Num At Risk
55
serious Num Affected
39
serious Num At Risk
55
title
Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg
deaths Num Affected
7
deaths Num At Risk
45
description
Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
id
EG008
other Num Affected
44
other Num At Risk
45
serious Num Affected
24
serious Num At Risk
45
title
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg
deaths Num Affected
1
deaths Num At Risk
15
description
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
id
EG009
other Num Affected
15
other Num At Risk
15
serious Num Affected
8
serious Num At Risk
15
title
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
deaths Num Affected
4
deaths Num At Risk
15
description
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
id
EG010
other Num Affected
15
other Num At Risk
15
serious Num Affected
11
serious Num At Risk
15
title
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
deaths Num Affected
7
deaths Num At Risk
41
description
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
id
EG011
other Num Affected
41
other Num At Risk
41
serious Num Affected
29
serious Num At Risk
41
title
Part D: Dabrafenib 75 mg + Trametinib 2 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
4
num At Risk
23
group Id
EG003
num Affected
3
num At Risk
27
group Id
EG004
num Affected
21
num At Risk
94
group Id
EG005
num Affected
3
num At Risk
53
group Id
EG006
num Affected
10
num At Risk
54
group Id
EG007
num Affected
12
num At Risk
55
group Id
EG008
num Affected
9
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
6
num At Risk
15
group Id
EG011
num Affected
8
num At Risk
41
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
5
num At Risk
23
group Id
EG003
num Affected
3
num At Risk
27
group Id
EG004
num Affected
8
num At Risk
94
group Id
EG005
num Affected
2
num At Risk
53
group Id
EG006
num Affected
2
num At Risk
54
group Id
EG007
num Affected
2
num At Risk
55
group Id
EG008
num Affected
3
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
1
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
3
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
3
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
2
num At Risk
41
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
3
num At Risk
23
group Id
EG003
num Affected
6
num At Risk
27
group Id
EG004
num Affected
11
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
8
num At Risk
54
group Id
EG007
num Affected
4
num At Risk
55
group Id
EG008
num Affected
2
num At Risk
45
group Id
EG009
num Affected
1
num At Risk
15
group Id
EG010
num Affected
2
num At Risk
15
group Id
EG011
num Affected
3
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
3
num At Risk
27
group Id
EG004
num Affected
10
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
2
num At Risk
54
group Id
EG007
num Affected
3
num At Risk
55
group Id
EG008
num Affected
1
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
1
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Intracardiac mass
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
3
num At Risk
53
group Id
EG006
num Affected
3
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
2
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
3
num At Risk
41
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
2
num At Risk
27
group Id
EG004
num Affected
7
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
3
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
2
num At Risk
41
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Dermoid cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
3
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Ear congestion

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
3
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
2
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Immune thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
2
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
2
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
1
num At Risk
41
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
1
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
1
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Atrial thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
1
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
0
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Cardiogenic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
27
group Id
EG004
num Affected
0
num At Risk
94
group Id
EG005
num Affected
0
num At Risk
53
group Id
EG006
num Affected
1
num At Risk
54
group Id
EG007
num Affected
0
num At Risk
55
group Id
EG008
num Affected
0
num At Risk
45
group Id
EG009
num Affected
0
num At Risk
15
group Id
EG010
num Affected
0
num At Risk
15
group Id
EG011
num Affected
0
num At Risk
41
term
Left ventricular dysfunction

time Frame

Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.

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

Preserved source evidence · Independent clinical review pending · Not medical advice