NCT03960437 · ADVERSE EVENTS

Adverse events

The Effect of Etelcalcetide on CKD-MBD · Source last updated 2023-09-21

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: 9 months after baseline
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Study Participant Every study participant will receive etelcalcetide prescribed by their treating physician for the duration of the study. Etelcalcetide: Administered intravenously at the end of each dialysis session. Dosing ranges from 5 mg to 15 mg set by the patient's physician.	3 / 22	2 / 22	2 / 22

Group identifiers: EG000: Study Participant

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
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
COVID-19 infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cardiac event was experienced during an AVF revision under anesthesia.
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Cardiac Event
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Subject was hospitalized for 2 weeks for vertigo/dizziness.
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Vertigo/Dizziness

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
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Cold Sores
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Gastrointestinal Disorder

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
22
description
Every study participant will receive etelcalcetide prescribed by their treating physician for the duration of the study. Etelcalcetide: Administered intravenously at the end of each dialysis session. Dosing ranges from 5 mg to 15 mg set by the patient's physician.
id
EG000
other Num Affected
2
other Num At Risk
22
serious Num Affected
3
serious Num At Risk
22
title
Study Participant

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Cold Sores
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Gastrointestinal Disorder

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
COVID-19 infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cardiac event was experienced during an AVF revision under anesthesia.
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Cardiac Event
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Subject was hospitalized for 2 weeks for vertigo/dizziness.
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Vertigo/Dizziness

time Frame

9 months after baseline

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

Preserved source evidence · Not medical advice