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NCT01259856 · ADVERSE EVENTS

Adverse events

Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) · Source last updated 2019-04-30

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
4 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PEGASYS

The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.

14 / 8279 / 820 / 82
Hydroxyurea

Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.

4 / 8676 / 861 / 86

Group identifiers: EG000: PEGASYS · EG001: Hydroxyurea

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
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Bile Duct Disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Cardiac arrhythmias
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Cardiac disorder signs and symptoms
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Electrolyte and fluid balance conditions
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Exocrine pancreas conditions
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Gastrointestinal haemorrahges NEC
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Gastrointestinal signs and symptoms
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    General system disorders NEC
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Headaches
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      86
    term
    Infections - pathogen unspecified
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Neoplasms benign, malignant and unspecified - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Platelet disorders

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    Abdominal Distenstion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    Abdominal hernias and other abdominal wall conditions
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    Abdominal Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Administration site reactions
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Administration site reactions
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Alanine aminotransferace increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      86
    term
    Allergic conditions
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      86
    term
    Anaemias nonhaemolytic and marrow depression
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Anxiety
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    Anxeity disorders and symptoms
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      86
    term
    Appetite and general nutrition disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      86
    term
    Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    82
    description
    The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
    id
    EG000
    other Num Affected
    79
    other Num At Risk
    82
    serious Num Affected
    14
    serious Num At Risk
    82
    title
    PEGASYS
  2. deaths Num Affected
    1
    deaths Num At Risk
    86
    description
    Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
    id
    EG001
    other Num Affected
    76
    other Num At Risk
    86
    serious Num Affected
    4
    serious Num At Risk
    86
    title
    Hydroxyurea
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    Abdominal Distenstion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    Abdominal hernias and other abdominal wall conditions
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    Abdominal Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Administration site reactions
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Administration site reactions
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Alanine aminotransferace increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      86
    term
    Allergic conditions
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      86
    term
    Anaemias nonhaemolytic and marrow depression
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Anxiety
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    Anxeity disorders and symptoms
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      86
    term
    Appetite and general nutrition disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      86
    term
    Arteriosclerosis, stenosis, vascular insufficiency and necrosis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Bile Duct Disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Cardiac arrhythmias
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Cardiac disorder signs and symptoms
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Electrolyte and fluid balance conditions
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Exocrine pancreas conditions
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Gastrointestinal haemorrahges NEC
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Gastrointestinal signs and symptoms
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      86
    term
    General system disorders NEC
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Headaches
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      86
    term
    Infections - pathogen unspecified
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Neoplasms benign, malignant and unspecified - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      86
    term
    Platelet disorders
time Frame
4 years

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Preserved source evidence · Not medical advice