NCT01227889 · ADVERSE EVENTS

Adverse events

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma · Source last updated 2017-10-04

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: Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the end of the study. The total duration of the study including a long-term follow-up phase was up to 5 years.
Other-event reporting threshold: 5%

SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of study drug, based on the actual treatment received, if this differed from that to which the participant was randomized.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
GSK2118436 150 mg BID Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.	64 / 187	181 / 187	5 / 187
DTIC 1000 mg/m^2 in RP In the RP, participants received IV DTIC 1000 mg/m\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.	14 / 59	51 / 59	0 / 59
GSK25118436 in the Crossover Phase Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.	9 / 37	37 / 37	1 / 37

Group identifiers: EG000: GSK2118436 150 mg BID · EG001: DTIC 1000 mg/m^2 in RP · EG002: GSK25118436 in the Crossover Phase

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
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
3
num At Risk
187
num Events
3
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
2
num At Risk
187
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Cataract

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
19.0
stats
group Id
EG000
num Affected
10
num At Risk
187
num Events
14
group Id
EG001
num Affected
7
num At Risk
59
num Events
9
group Id
EG002
num Affected
3
num At Risk
37
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
8
num At Risk
59
num Events
8
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
10
num At Risk
59
num Events
18
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
8
num At Risk
59
num Events
11
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
15
num At Risk
187
num Events
16
group Id
EG001
num Affected
7
num At Risk
59
num Events
8
group Id
EG002
num Affected
8
num At Risk
37
num Events
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
11
num At Risk
187
num Events
20
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
3
num At Risk
37
num Events
4
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
27
num At Risk
187
num Events
32
group Id
EG001
num Affected
8
num At Risk
59
num Events
9
group Id
EG002
num Affected
4
num At Risk
37
num Events
4
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
31
num At Risk
187
num Events
42
group Id
EG001
num Affected
7
num At Risk
59
num Events
8
group Id
EG002
num Affected
4
num At Risk
37
num Events
5
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
55
num At Risk
187
num Events
69
group Id
EG001
num Affected
29
num At Risk
59
num Events
49
group Id
EG002
num Affected
9
num At Risk
37
num Events
9
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
42
num At Risk
187
num Events
55
group Id
EG001
num Affected
15
num At Risk
59
num Events
19
group Id
EG002
num Affected
5
num At Risk
37
num Events
5
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
37
num At Risk
187
num Events
56
group Id
EG001
num Affected
9
num At Risk
59
num Events
11
group Id
EG002
num Affected
6
num At Risk
37
num Events
8
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
23
num At Risk
187
num Events
40
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
4
num At Risk
37
num Events
5
term
Chills

Complete source fields

description

event Groups

deaths Num Affected
5
deaths Num At Risk
187
description
Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
id
EG000
other Num Affected
181
other Num At Risk
187
serious Num Affected
64
serious Num At Risk
187
title
GSK2118436 150 mg BID
deaths Num Affected
0
deaths Num At Risk
59
description
In the RP, participants received IV DTIC 1000 mg/m\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
id
EG001
other Num Affected
51
other Num At Risk
59
serious Num Affected
14
serious Num At Risk
59
title
DTIC 1000 mg/m^2 in RP
deaths Num Affected
1
deaths Num At Risk
37
description
Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
id
EG002
other Num Affected
37
other Num At Risk
37
serious Num Affected
9
serious Num At Risk
37
title
GSK25118436 in the Crossover Phase

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
10
num At Risk
187
num Events
14
group Id
EG001
num Affected
7
num At Risk
59
num Events
9
group Id
EG002
num Affected
3
num At Risk
37
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
8
num At Risk
59
num Events
8
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
10
num At Risk
59
num Events
18
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
8
num At Risk
59
num Events
11
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
15
num At Risk
187
num Events
16
group Id
EG001
num Affected
7
num At Risk
59
num Events
8
group Id
EG002
num Affected
8
num At Risk
37
num Events
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
11
num At Risk
187
num Events
20
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
3
num At Risk
37
num Events
4
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
27
num At Risk
187
num Events
32
group Id
EG001
num Affected
8
num At Risk
59
num Events
9
group Id
EG002
num Affected
4
num At Risk
37
num Events
4
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
31
num At Risk
187
num Events
42
group Id
EG001
num Affected
7
num At Risk
59
num Events
8
group Id
EG002
num Affected
4
num At Risk
37
num Events
5
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
55
num At Risk
187
num Events
69
group Id
EG001
num Affected
29
num At Risk
59
num Events
49
group Id
EG002
num Affected
9
num At Risk
37
num Events
9
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
42
num At Risk
187
num Events
55
group Id
EG001
num Affected
15
num At Risk
59
num Events
19
group Id
EG002
num Affected
5
num At Risk
37
num Events
5
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
37
num At Risk
187
num Events
56
group Id
EG001
num Affected
9
num At Risk
59
num Events
11
group Id
EG002
num Affected
6
num At Risk
37
num Events
8
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
23
num At Risk
187
num Events
40
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
4
num At Risk
37
num Events
5
term
Chills

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
0
num At Risk
187
num Events
0
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
3
num At Risk
187
num Events
3
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
2
num At Risk
187
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
19.0
stats
group Id
EG000
num Affected
1
num At Risk
187
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
group Id
EG002
num Affected
0
num At Risk
37
num Events
0
term
Cataract

time Frame

Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the end of the study. The total duration of the study including a long-term follow-up phase was up to 5 years.

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

Preserved source evidence · Not medical advice