NCT01439724 · ADVERSE EVENTS

Adverse events

Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients · Source last updated 2014-04-11

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: 3 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light. Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.	17 / 47	17 / 47	Not reported / Not reported
Low Level Laser Therapy The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region. Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.	15 / 47	10 / 47	Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Low Level Laser Therapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned radiotherapy interruptions due to radiodermatis: Laser group = 7 patients and Placebo group = 4 patients
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
47
num Events
4
group Id
EG001
num Affected
7
num At Risk
47
num Events
7
term
Radiodermatitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned radiotherapy interruptions due to pneumonia
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
47
num Events
1
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned chemotherapy interruptions or modification
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
47
num Events
5
group Id
EG001
num Affected
3
num At Risk
47
num Events
3
term
Renal and urinary disorders
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned chemotherapy interruptions or modification
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
47
num Events
3
group Id
EG001
num Affected
4
num At Risk
47
num Events
4
term
Ear and labyrinth disorders
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned chemotherapy interruptions or modification
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
47
num Events
4
group Id
EG001
num Affected
0
num At Risk
47
num Events
0
term
Blood and lymphatic system disorders

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Distribution of severe oral pain intensity
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
17
num At Risk
47
num Events
17
group Id
EG001
num Affected
10
num At Risk
47
num Events
10
term
Gastrointestinal disorders

Complete source fields

event Groups

description
Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light. Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
id
EG000
other Num Affected
17
other Num At Risk
47
serious Num Affected
17
serious Num At Risk
47
title
Placebo
description
The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region. Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
id
EG001
other Num Affected
10
other Num At Risk
47
serious Num Affected
15
serious Num At Risk
47
title
Low Level Laser Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Distribution of severe oral pain intensity
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
17
num At Risk
47
num Events
17
group Id
EG001
num Affected
10
num At Risk
47
num Events
10
term
Gastrointestinal disorders

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned radiotherapy interruptions due to radiodermatis: Laser group = 7 patients and Placebo group = 4 patients
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
47
num Events
4
group Id
EG001
num Affected
7
num At Risk
47
num Events
7
term
Radiodermatitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned radiotherapy interruptions due to pneumonia
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
47
num Events
1
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned chemotherapy interruptions or modification
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
47
num Events
5
group Id
EG001
num Affected
3
num At Risk
47
num Events
3
term
Renal and urinary disorders
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned chemotherapy interruptions or modification
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
47
num Events
3
group Id
EG001
num Affected
4
num At Risk
47
num Events
4
term
Ear and labyrinth disorders
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unplanned chemotherapy interruptions or modification
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
47
num Events
4
group Id
EG001
num Affected
0
num At Risk
47
num Events
0
term
Blood and lymphatic system disorders

time Frame

3 years

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Preserved source evidence · Not medical advice