NCT02254551 · ADVERSE EVENTS

Adverse events

Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2017-02-16

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: Treatment-emergent adverse events were collected on Days 1 and 8 of every 21-day cycle for up to 48 weeks (plus 30 days for end of treatment visit).
Other-event reporting threshold: 0%

All patients who received at least one dose of LDE225 plus bortezomib.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1: LDE225 400mg/m^2 Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m\^2 every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.	2 / 7	6 / 7	Not reported / Not reported
Cohort 2: LDE225 600mg/m^2 Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.	0 / 0	0 / 0	Not reported / Not reported
Cohort 3: LDE225 800mg/m^2 Cohort 3 will receive LDE225 orally on a daily basis, at 800mg/m\^2 every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.	0 / 0	0 / 0	Not reported / Not reported

Group identifiers: EG000: Cohort 1: LDE225 400mg/m^2 · EG001: Cohort 2: LDE225 600mg/m^2 · EG002: Cohort 3: LDE225 800mg/m^2

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events 4.03
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Viral Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Sepsis

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Atelectasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Increased creatinine
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
5
num At Risk
7
num Events
5
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Decreased creatinine clearance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
4
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Vomiting

Complete source fields

description

All patients who received at least one dose of LDE225 plus bortezomib.

event Groups

description
Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m\^2 every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
id
EG000
other Num Affected
6
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Cohort 1: LDE225 400mg/m^2
description
Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Cohort 2: LDE225 600mg/m^2
description
Cohort 3 will receive LDE225 orally on a daily basis, at 800mg/m\^2 every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Cohort 3: LDE225 800mg/m^2

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Atelectasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Increased creatinine
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
5
num At Risk
7
num Events
5
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Decreased creatinine clearance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
4
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTCAE 4.03
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Vomiting

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events 4.03
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Viral Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
term
Sepsis

time Frame

Treatment-emergent adverse events were collected on Days 1 and 8 of every 21-day cycle for up to 48 weeks (plus 30 days for end of treatment visit).

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Preserved source evidence · Not medical advice