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NCT04711135 · ADVERSE EVENTS

Adverse events

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs · Source last updated 2026-02-12

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
AEs & on-treatment deaths were collected from the first dose of study treatment up to data cut-off date of 12-Mar-2024, approx. 19 months from the FPFV.
Other-event reporting threshold
5%

Any sign or symptom that occurs during the conduct of the trial.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
GEP-NET

All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.

1 / 44 / 40 / 4
PPGL

All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.

1 / 77 / 70 / 7
Total

All participants from the GEP-NET and PPGL arms.

2 / 1111 / 110 / 11

Group identifiers: EG000: GEP-NET · EG001: PPGL · EG002: Total

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
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Lower gastrointestinal haemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Device related infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Hypercalcaemia

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
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Photophobia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Diarrhoea
Complete source fields
description
Any sign or symptom that occurs during the conduct of the trial.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    GEP-NET
  2. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    PPGL
  3. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    All participants from the GEP-NET and PPGL arms.
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    2
    serious Num At Risk
    11
    title
    Total
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Photophobia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Lower gastrointestinal haemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Device related infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Hypercalcaemia
time Frame
AEs & on-treatment deaths were collected from the first dose of study treatment up to data cut-off date of 12-Mar-2024, approx. 19 months from the FPFV.

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Preserved source evidence · Not medical advice