NCT01346267 · ADVERSE EVENTS

Adverse events

Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy · Source last updated 2021-08-18

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: First application of wrist bands through 8 days after administration of the last chemotherapy dose of the cisplatin-containing course.
Other-event reporting threshold: 5%

Adverse events could spontaneously be communicated by the patient/family and/or elicited via the Final Questionnaire.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I- Real Acupressure Bands Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference. Real Acupressure Band: Acupressure wristband	0 / 83	0 / 83	0 / 83
Arm II- Placebo Acupressure Bands Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I. Placebo Acupressure Band: Sham wristband	0 / 82	0 / 82	0 / 82

Group identifiers: EG000: Arm I- Real Acupressure Bands · EG001: Arm II- Placebo Acupressure Bands

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

Adverse events could spontaneously be communicated by the patient/family and/or elicited via the Final Questionnaire.

event Groups

deaths Num Affected
0
deaths Num At Risk
83
description
Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference. Real Acupressure Band: Acupressure wristband
id
EG000
other Num Affected
0
other Num At Risk
83
serious Num Affected
0
serious Num At Risk
83
title
Arm I- Real Acupressure Bands
deaths Num Affected
0
deaths Num At Risk
82
description
Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I. Placebo Acupressure Band: Sham wristband
id
EG001
other Num Affected
0
other Num At Risk
82
serious Num Affected
0
serious Num At Risk
82
title
Arm II- Placebo Acupressure Bands

frequency Threshold

time Frame

First application of wrist bands through 8 days after administration of the last chemotherapy dose of the cisplatin-containing course.

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Preserved source evidence · Not medical advice