NCT02068157 · ADVERSE EVENTS

Adverse events

Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer · Source last updated 2017-10-11

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Porfimer Sodium, Image-guided I-PDT) Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. Laboratory Biomarker Analysis: Correlative studies Photodynamic Therapy: Undergo image-guided I-PDT Porfimer Sodium: Given IV	1 / 3	3 / 3	Not reported / Not reported

Group identifiers: EG000: Treatment (Porfimer Sodium, Image-guided I-PDT)

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
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
35
term
Pain

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
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
23
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
9
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
6
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
5
term
Eye swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
26
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
9
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Sunburn
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
6
term
Hypokalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
10
term
Hyponatraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
7
term
Trismus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
5
term
Haemoptysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
9
term
Pneumonia aspiration

Complete source fields

event Groups

description
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. Laboratory Biomarker Analysis: Correlative studies Photodynamic Therapy: Undergo image-guided I-PDT Porfimer Sodium: Given IV
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Treatment (Porfimer Sodium, Image-guided I-PDT)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
23
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
9
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
6
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
5
term
Eye swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
26
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
9
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Sunburn
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
6
term
Hypokalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
10
term
Hyponatraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
7
term
Trismus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
5
term
Haemoptysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
9
term
Pneumonia aspiration

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
35
term
Pain

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

Preserved source evidence · Not medical advice