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NCT03724253 · ADVERSE EVENTS

Adverse events

[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR) · Source last updated 2020-10-23

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
Adverse events (AEs) were collected from informed consent signature through study completion (Day 14).
Other-event reporting threshold
5%

Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.

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

All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

0 / 50 / 50 / 5
Prostate

All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

0 / 51 / 50 / 5
Colorectal

All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

0 / 53 / 50 / 5
Non-Small Cell Lung Cancer (NSCLC)

All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

0 / 33 / 30 / 3
Small-Cell Lung Cancer (SCLC)

All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

1 / 11 / 10 / 1

Group identifiers: EG000: Breast · EG001: Prostate · EG002: Colorectal · EG003: Non-Small Cell Lung Cancer (NSCLC) · EG004: Small-Cell Lung Cancer (SCLC)

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 (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Hyponatraemia

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 (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Hyperfibrinogenaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Hyperparathyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Post procedural constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Procedural pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Blood cholinesterase decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Blood creatine phosphokinase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Blood lactate dehydrogenase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Blood urea decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    C-reactive protein increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Gamma-glutamyltransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Hyperalbuminaemia
Complete source fields
description
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Breast
  2. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Prostate
  3. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Colorectal
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Non-Small Cell Lung Cancer (NSCLC)
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Small-Cell Lung Cancer (SCLC)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Hyperfibrinogenaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Hyperparathyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Post procedural constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Procedural pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Blood cholinesterase decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Blood creatine phosphokinase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Blood lactate dehydrogenase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Blood urea decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    C-reactive protein increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Gamma-glutamyltransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Hyperalbuminaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Hyponatraemia
time Frame
Adverse events (AEs) were collected from informed consent signature through study completion (Day 14).

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