NCT02943473 · ADVERSE EVENTS

Adverse events

Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients · Source last updated 2020-12-16

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: 1 year
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ibrutinib Ibrutinib (trademark name is IMBRUVICA®). 560 mg dose administered on a continuous basis Ibrutinib: Ibrutinib is a type of drug called a "kinase inhibitor." Kinases are proteins inside cells that help cells live and grow. Ibrutinib blocks a specific kinase protein in our bodies. This protein is thought to be very important in helping blood cancer cells live and grow. By blocking this kinase protein, ibrutinib stops cancer cells from growing.	0 / 3	3 / 3	0 / 3

Group identifiers: EG000: Ibrutinib

Serious adverse events

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

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
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Tingling in Tongue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Irregular menses
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Loose stools
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Leg cramps

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Ibrutinib (trademark name is IMBRUVICA®). 560 mg dose administered on a continuous basis Ibrutinib: Ibrutinib is a type of drug called a "kinase inhibitor." Kinases are proteins inside cells that help cells live and grow. Ibrutinib blocks a specific kinase protein in our bodies. This protein is thought to be very important in helping blood cancer cells live and grow. By blocking this kinase protein, ibrutinib stops cancer cells from growing.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Ibrutinib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Tingling in Tongue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Irregular menses
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Loose stools
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Leg cramps

time Frame

1 year

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

Preserved source evidence · Not medical advice