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NCT00538850 · ADVERSE EVENTS

Adverse events

Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain · Source last updated 2014-03-05

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
All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Other-event reporting threshold
0%

Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Fentanyl Sublingual Spray - Titration

In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.

7 / 13078 / 130Not reported / Not reported
Fentanyl Sublingual Spray - Double-blind

Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.

6 / 9847 / 98Not reported / Not reported

Group identifiers: EG000: Fentanyl Sublingual Spray - Titration · EG001: Fentanyl Sublingual Spray - Double-blind

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Lung cancer metastatic
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Malignant neoplasm progression
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Metastases to bone
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Spinal cord neoplasm
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Leukopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Hyponatraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Fistula
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Gastroenteritis Viral

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      98
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      98
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      98
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      98
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Flatulence
Complete source fields
description
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
event Groups
  1. description
    In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
    id
    EG000
    other Num Affected
    78
    other Num At Risk
    130
    serious Num Affected
    7
    serious Num At Risk
    130
    title
    Fentanyl Sublingual Spray - Titration
  2. description
    Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
    id
    EG001
    other Num Affected
    47
    other Num At Risk
    98
    serious Num Affected
    6
    serious Num At Risk
    98
    title
    Fentanyl Sublingual Spray - Double-blind
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      98
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      98
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      98
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      98
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Flatulence
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Lung cancer metastatic
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Malignant neoplasm progression
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Metastases to bone
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Spinal cord neoplasm
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Leukopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Hyponatraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Fistula
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Gastroenteritis Viral
time Frame
All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.

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