NCT02123511 · OUTCOME

Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event

Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy · Source last updated 2019-04-30

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 90 days after completion of radiation therapy

What was measured

The maximum grade for each type of toxicity will be recorded for each patient. The overall adverse event rates (percentages) for adverse events are reported below.

Groups in this outcome

Arm A (Placebo)

Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.

Arm B (Rincinol)

Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Arm A (Placebo)	17
Arm B (Rincinol)	15

Reported measurements

Missing

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Placebo)	0	Not reported	Not reported	Not reported	Not reported
Arm B (Rincinol)	1	Not reported	Not reported	Not reported	Not reported

Grade 0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Placebo)	2	Not reported	Not reported	Not reported	Not reported
Arm B (Rincinol)	0	Not reported	Not reported	Not reported	Not reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Placebo)	3	Not reported	Not reported	Not reported	Not reported
Arm B (Rincinol)	5	Not reported	Not reported	Not reported	Not reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Placebo)	4	Not reported	Not reported	Not reported	Not reported
Arm B (Rincinol)	6	Not reported	Not reported	Not reported	Not reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Placebo)	8	Not reported	Not reported	Not reported	Not reported
Arm B (Rincinol)	3	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3824
statistical Method
Wilcoxon (Mann-Whitney)

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3824
statistical Method
Wilcoxon (Mann-Whitney)

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Missing
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Grade 0
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
title
Grade 1
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
6
title
Grade 2
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
3
title
Grade 3

denoms

counts
group Id
OG000
value
17
group Id
OG001
value
15
units
Participants

description

The maximum grade for each type of toxicity will be recorded for each patient. The overall adverse event rates (percentages) for adverse events are reported below.

groups

description
Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
id
OG000
title
Arm A (Placebo)
description
Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
id
OG001
title
Arm B (Rincinol)

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Up to 90 days after completion of radiation therapy

title

Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice