NCT04080531 · ADVERSE EVENTS

Adverse events

Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders · Source last updated 2025-02-28

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: 2%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Trivalent Influenza Vaccine, Prevnar) Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM	0 / 80	0 / 80	3 / 80
Arm II (Trivalent Influenza Vaccine, Prevnar) Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM	0 / 85	0 / 85	1 / 85

Group identifiers: EG000: Arm I (Trivalent Influenza Vaccine, Prevnar) · EG001: Arm II (Trivalent Influenza Vaccine, Prevnar)

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.

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
80
description
Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM
id
EG000
other Num Affected
0
other Num At Risk
80
serious Num Affected
0
serious Num At Risk
80
title
Arm I (Trivalent Influenza Vaccine, Prevnar)
deaths Num Affected
1
deaths Num At Risk
85
description
Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM
id
EG001
other Num Affected
0
other Num At Risk
85
serious Num Affected
0
serious Num At Risk
85
title
Arm II (Trivalent Influenza Vaccine, Prevnar)

frequency Threshold

time Frame

1 year

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

Preserved source evidence · Not medical advice