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NCT01964300 · ADVERSE EVENTS

Adverse events

Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery · Source last updated 2020-02-24

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
Up to 2 years after start of treatment
Other-event reporting threshold
0%

Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All grades 3 through 5 adverse events while on treatment or within 30 days of treatment were to be collected, in addition to grades 1 and 2 adverse events if the attribution was at least possibly related. All adverse events collected and reported in the study database are reported here.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Stratum 1

Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.

1 / 77 / 70 / 7
Stratum 2

Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity. Since the ineligible patient received 2 days of Peginterferon alfa-2b, that patient is included in all adverse event reporting results.

5 / 1212 / 121 / 12

Group identifiers: EG000: Stratum 1 · EG001: Stratum 2

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Catheter related infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Fall
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Neutrophil count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Hypernatremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Generalized muscle weakness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Muscle weakness right-sided
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Treatment related secondary malignancy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    Ataxia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Dizziness

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Blurred vision
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Floaters
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Optic nerve disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Photophobia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastrointestinal disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Mucositis oral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
      num Events
      5
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Chills
Complete source fields
description
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All grades 3 through 5 adverse events while on treatment or within 30 days of treatment were to be collected, in addition to grades 1 and 2 adverse events if the attribution was at least possibly related. All adverse events collected and reported in the study database are reported here.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Stratum 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    12
    description
    Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity. Since the ineligible patient received 2 days of Peginterferon alfa-2b, that patient is included in all adverse event reporting results.
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    5
    serious Num At Risk
    12
    title
    Stratum 2
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Blurred vision
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Floaters
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Optic nerve disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Photophobia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastrointestinal disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Mucositis oral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
      num Events
      5
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Chills
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Catheter related infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Fall
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Neutrophil count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Hypernatremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Generalized muscle weakness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Muscle weakness right-sided
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Treatment related secondary malignancy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    Ataxia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Dizziness
time Frame
Up to 2 years after start of treatment

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