NCT01242800 · ADVERSE EVENTS

Adverse events

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer · Source last updated 2023-06-29

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: The trial involved standard of care systemic therapies and there could be many options of systemic therapies, adverse events data were not collected in the trial. For all-cause mortality, it was assessed every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years.
Other-event reporting threshold: 0%

The trial involved standard of care systemic therapies and there could be several options of systemic therapies, adverse events data were not collected in the trial.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Continued Systemic Therapy) Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy	0 / 0	0 / 0	63 / 131
Arm II (Early Local Therapy) Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy	0 / 0	0 / 0	58 / 125

Group identifiers: EG000: Arm I (Continued Systemic Therapy) · EG001: Arm II (Early Local Therapy)

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

description

The trial involved standard of care systemic therapies and there could be several options of systemic therapies, adverse events data were not collected in the trial.

event Groups

deaths Num Affected
63
deaths Num At Risk
131
description
Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Arm I (Continued Systemic Therapy)
deaths Num Affected
58
deaths Num At Risk
125
description
Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Arm II (Early Local Therapy)

frequency Threshold

time Frame

The trial involved standard of care systemic therapies and there could be many options of systemic therapies, adverse events data were not collected in the trial. For all-cause mortality, it was assessed every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years.

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Preserved source evidence · Not medical advice