NCT01989598 · ADVERSE EVENTS

Adverse events

Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2022-03-02

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: From treatment start until 4 weeks after treatment end or death (whichever occurs first), for each patient, an average of 1 year.
Other-event reporting threshold: 5%

Adverse events collected as per protocol using CTCAE version 4.0

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Trametinib, Akt Inhibitor GSK2141795) Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or who achieve less than PR after 4 courses may also receive Akt inhibitor GSK2141795 PO daily on days 1-28. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Trametinib: Given PO Uprosertib: Given PO	15 / 25	25 / 25	7 / 25

Group identifiers: EG000: Treatment (Trametinib, Akt Inhibitor GSK2141795)

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
notes
Sepsis
organ System
Infections and infestations
stats
group Id
EG000
num Affected
6
num At Risk
25
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Lung infection
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Intracranial hemorrhage
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Intracranial hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
notes
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)-OTHER, PROGRESSIVE DISEASE
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
2
num At Risk
25
term
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Confusion
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
3
num At Risk
25
term
Confusion

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
notes
Platelet count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
13
num At Risk
25
term
thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
14
num At Risk
25
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Rash
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
17
num At Risk
25
term
Rash

Complete source fields

description

Adverse events collected as per protocol using CTCAE version 4.0

event Groups

deaths Num Affected
7
deaths Num At Risk
25
description
Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or who achieve less than PR after 4 courses may also receive Akt inhibitor GSK2141795 PO daily on days 1-28. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Trametinib: Given PO Uprosertib: Given PO
id
EG000
other Num Affected
25
other Num At Risk
25
serious Num Affected
15
serious Num At Risk
25
title
Treatment (Trametinib, Akt Inhibitor GSK2141795)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Platelet count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
13
num At Risk
25
term
thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
14
num At Risk
25
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Rash
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
17
num At Risk
25
term
Rash

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Sepsis
organ System
Infections and infestations
stats
group Id
EG000
num Affected
6
num At Risk
25
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Lung infection
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Intracranial hemorrhage
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Intracranial hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
notes
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)-OTHER, PROGRESSIVE DISEASE
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
2
num At Risk
25
term
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Confusion
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
3
num At Risk
25
term
Confusion

time Frame

From treatment start until 4 weeks after treatment end or death (whichever occurs first), for each patient, an average of 1 year.

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

Preserved source evidence · Not medical advice