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NCT00453336 · ADVERSE EVENTS

Adverse events

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract · Source last updated 2017-02-08

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 groupSerious eventsOther eventsDeaths
Single Arm

Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired. Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.

24 / 4512 / 45Not reported / Not reported

Group identifiers: EG000: Single Arm

Serious adverse events

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

  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Unfortunate Airway Disaster
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      45
      num Events
      23
    term
    Significant Postoperative Pain for Oral Lesions

Other reported adverse events

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

  1. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      45
      num Events
      8
    term
    Mild Skin Irritation
  2. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Transient second-degree burn on the back of the hand
  3. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Inflammatory Reaction from Extravasation of Porfimer Sodium at the Intravenous Site
  4. organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Transient Aspiration
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Temporary edema requiring tracheotomy
Complete source fields
event Groups
  1. description
    Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired. Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    45
    serious Num Affected
    24
    serious Num At Risk
    45
    title
    Single Arm
frequency Threshold
0
other Events
  1. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      45
      num Events
      8
    term
    Mild Skin Irritation
  2. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Transient second-degree burn on the back of the hand
  3. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Inflammatory Reaction from Extravasation of Porfimer Sodium at the Intravenous Site
  4. organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Transient Aspiration
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Temporary edema requiring tracheotomy
serious Events
  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Unfortunate Airway Disaster
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      45
      num Events
      23
    term
    Significant Postoperative Pain for Oral Lesions

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Preserved source evidence · Not medical advice