Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01578239 · ADVERSE EVENTS

Adverse events

A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours · Source last updated 2022-04-04

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
From informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months.
Other-event reporting threshold
5%

Any sign or symptom that occurs after written informed consent provided.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
177Lu-DOTA0-Tyr3-Octreotate

* 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.

40 / 111105 / 11170 / 111
Octreotide LAR

* 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.

31 / 11290 / 11268 / 112

Group identifiers: EG000: 177Lu-DOTA0-Tyr3-Octreotate · EG001: Octreotide LAR

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Myelodysplastic syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Refractory cytopenia with unilineage dysplasia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    term
    Arteriospasm coronary
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Atrioventricular block second degree
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Silent myocardial infarction

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 (18.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      112
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      112
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      112
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      112
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      112
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      112
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      112
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      112
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      112
    term
    Flatulence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      112
    term
    Nausea
Complete source fields
description
Any sign or symptom that occurs after written informed consent provided.
event Groups
  1. deaths Num Affected
    70
    deaths Num At Risk
    111
    description
    * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.
    id
    EG000
    other Num Affected
    105
    other Num At Risk
    111
    serious Num Affected
    40
    serious Num At Risk
    111
    title
    177Lu-DOTA0-Tyr3-Octreotate
  2. deaths Num Affected
    68
    deaths Num At Risk
    112
    description
    * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
    id
    EG001
    other Num Affected
    90
    other Num At Risk
    112
    serious Num Affected
    31
    serious Num At Risk
    112
    title
    Octreotide LAR
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      112
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      112
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      112
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      112
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      112
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      112
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      112
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      112
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      112
    term
    Flatulence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      112
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Myelodysplastic syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Refractory cytopenia with unilineage dysplasia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    term
    Arteriospasm coronary
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Atrioventricular block second degree
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    term
    Silent myocardial infarction
time Frame
From informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice