NCT01966809 · ADVERSE EVENTS

Adverse events

Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas · Source last updated 2019-08-20

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: 6 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Photofrin Photodynamic Therapy. Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.	1 / 1	0 / 1	0 / 1

Group identifiers: EG000: Photofrin Photodynamic 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
NON_SYSTEMATIC_ASSESSMENT
notes
Change in the patient's mentation as well as decreased strength on the right side.
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Altered mental status

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

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.
id
EG000
other Num Affected
0
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Photofrin Photodynamic Therapy.

frequency Threshold

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Change in the patient's mentation as well as decreased strength on the right side.
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Altered mental status

time Frame

6 months

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

Preserved source evidence · Not medical advice