NCT01843673 · ADVERSE EVENTS

Adverse events

Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer · Source last updated 2016-07-06

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: Adverse Event Reporting were collected up to 7 weeks while the patient was undergoing the course of radiation therapy. No adverse events occurred due to additional xray imaging from this study.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Diagnostic (Imaging Technology) Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART. computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART	1 / 16	7 / 16	Not reported / Not reported

Group identifiers: EG000: Diagnostic (Imaging Technology)

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
Death not associated with CTCAE term - Sudden death. Cause of Death, SEPSIS-ASSOCIATED ORGAN DYSFUNCTION
organ System
Infections and infestations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
SEPSIS-ASSOCIATED ORGAN DYSFUNCTION

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
Metabolic/Laboratory, Glomerular filtration rate grade 1 and grade 2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Below normal Glomerular filtration rate (GFR)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
3 events grade 1 and 4 events grade 2.
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
6
num At Risk
16
num Events
7
term
Elevated Creatinine
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Metabolic/Laboratory - Other (Specify, \_\_)
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Elevated Blood Urea Nitrogen (BUN)

Complete source fields

event Groups

description
Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART. computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART
id
EG000
other Num Affected
7
other Num At Risk
16
serious Num Affected
1
serious Num At Risk
16
title
Diagnostic (Imaging Technology)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Metabolic/Laboratory, Glomerular filtration rate grade 1 and grade 2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Below normal Glomerular filtration rate (GFR)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
3 events grade 1 and 4 events grade 2.
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
6
num At Risk
16
num Events
7
term
Elevated Creatinine
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Metabolic/Laboratory - Other (Specify, \_\_)
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Elevated Blood Urea Nitrogen (BUN)

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death not associated with CTCAE term - Sudden death. Cause of Death, SEPSIS-ASSOCIATED ORGAN DYSFUNCTION
organ System
Infections and infestations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
SEPSIS-ASSOCIATED ORGAN DYSFUNCTION

time Frame

Adverse Event Reporting were collected up to 7 weeks while the patient was undergoing the course of radiation therapy. No adverse events occurred due to additional xray imaging from this study.

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Preserved source evidence · Not medical advice