NCT02400437 · ADVERSE EVENTS

Adverse events

Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia · Source last updated 2020-09-02

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: Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ixazomib, Dexamethasone, Rituximab \- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity * Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long. * Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase * Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase * Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Rituximab: Doses given on Day 1 of induction and maintenance cycles.	4 / 26	25 / 26	0 / 26

Group identifiers: EG000: Ixazomib, Dexamethasone, Rituximab

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
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Renal Cell Carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Shortness of Breath
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Failure to thrive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Pleural Effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Heart Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Flu-like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Staph Aureus Bacteremia

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
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
3
num At Risk
26
num Events
3
term
Blurry vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Retinal detachment

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
26
description
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity * Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long. * Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase * Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase * Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Rituximab: Doses given on Day 1 of induction and maintenance cycles.
id
EG000
other Num Affected
25
other Num At Risk
26
serious Num Affected
4
serious Num At Risk
26
title
Ixazomib, Dexamethasone, Rituximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
3
num At Risk
26
num Events
3
term
Blurry vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Retinal detachment

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Renal Cell Carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Shortness of Breath
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Failure to thrive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Pleural Effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Heart Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Flu-like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
SNOMED CT
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Staph Aureus Bacteremia

time Frame

Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.

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Preserved source evidence · Not medical advice