NCT01696994 · ADVERSE EVENTS

Adverse events

Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial) · Source last updated 2026-07-24

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: During each annual screening visit.
Other-event reporting threshold: 0%

These events are solely those prompted by the screening examination.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ovarian Screening Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.	0 / 34253	903 / 34253	Not reported / Not reported

Group identifiers: EG000: Ovarian Screening

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
34253
num Events
3
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
26
num At Risk
34253
num Events
27
term
Bleeding
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
80
num At Risk
34253
num Events
82
term
Dizzy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
29
num At Risk
34253
num Events
31
term
Fainted
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
34253
num Events
2
term
Inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
34253
num Events
4
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
26
num At Risk
34253
num Events
26
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
446
num At Risk
34253
num Events
453
term
Bruising
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
284
num At Risk
34253
num Events
292
term
Hematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
34253
num Events
3
term
Other Adverse Event

Complete source fields

description

These events are solely those prompted by the screening examination.

event Groups

description
Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
id
EG000
other Num Affected
903
other Num At Risk
34253
serious Num Affected
0
serious Num At Risk
34253
title
Ovarian Screening

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
34253
num Events
3
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
26
num At Risk
34253
num Events
27
term
Bleeding
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
80
num At Risk
34253
num Events
82
term
Dizzy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
29
num At Risk
34253
num Events
31
term
Fainted
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
34253
num Events
2
term
Inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
34253
num Events
4
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
26
num At Risk
34253
num Events
26
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
446
num At Risk
34253
num Events
453
term
Bruising
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
284
num At Risk
34253
num Events
292
term
Hematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
34253
num Events
3
term
Other Adverse Event

time Frame

During each annual screening visit.

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Preserved source evidence · Not medical advice