NCT02667626 · ADVERSE EVENTS

Adverse events

Reproductive Health Survivorship Care Plan · Source last updated 2020-04-20

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: 6 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
SCPR Intervention Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.	0 / 86	0 / 86	0 / 86
Control Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders	0 / 96	0 / 96	0 / 96

Group identifiers: EG000: SCPR Intervention · EG001: Control

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
0
deaths Num At Risk
86
description
Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.
id
EG000
other Num Affected
0
other Num At Risk
86
serious Num Affected
0
serious Num At Risk
86
title
SCPR Intervention
deaths Num Affected
0
deaths Num At Risk
96
description
Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders
id
EG001
other Num Affected
0
other Num At Risk
96
serious Num Affected
0
serious Num At Risk
96
title
Control

frequency Threshold

time Frame

6 months

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

Preserved source evidence · Not medical advice