NCT01536392 · FLOW

Participant flow

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation · Source last updated 2021-06-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.
id
FG000
title
Arm 1: Transdermal Granisetron
description
8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
id
FG001
title
Arm 2: Oral Ondansetron

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
2
type
Adverse Event
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
3
type
Physician Decision
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
6
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
4
type
Non Compliance
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
0
type
Completed therapy early
milestones
achievements
group Id
FG000
num Subjects
41
group Id
FG001
num Subjects
34
type
STARTED
achievements
group Id
FG000
num Subjects
28
group Id
FG001
num Subjects
19
type
COMPLETED
achievements
group Id
FG000
num Subjects
13
group Id
FG001
num Subjects
15
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

76 participants signed consent, 1 participant did not receive treatment due to the study closure.

recruitment Details

Recruitment period: March 2012 until June 2016. All the recruitment was done in a medical clinic setting.

Complete source fields