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NCT05787496 · ADVERSE EVENTS

Adverse events

A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms · Source last updated 2026-01-28

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 first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
2mg/kg NC525

Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1

3 / 33 / 33 / 3
2.5mg/kg NC525

Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1

2 / 44 / 44 / 4
4.5mg/kg NC525

Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1

2 / 33 / 33 / 3
9mg/kg NC525

Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1

9 / 1111 / 119 / 11
13.5mg/kg NC525

Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1

4 / 44 / 42 / 4
18mg/kg NC525

Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1

3 / 33 / 32 / 3

Group identifiers: EG000: 2mg/kg NC525 · EG001: 2.5mg/kg NC525 · EG002: 4.5mg/kg NC525 · EG003: 9mg/kg NC525 · EG004: 13.5mg/kg NC525 · EG005: 18mg/kg NC525

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Extrasystoles
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Conjunctival haemorrhage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Lower gastrointestinal haemorrhage
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Oesophagitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Upper gastrointestinal haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Disease progression
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Pyrexia

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Atrial flutter
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Pericardial effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Sinus bradycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Ear congestion
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Ear pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Hypoacusis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Dry eye
Complete source fields
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    2mg/kg NC525
  2. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    2.5mg/kg NC525
  3. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    4.5mg/kg NC525
  4. deaths Num Affected
    9
    deaths Num At Risk
    11
    description
    Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
    id
    EG003
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    9
    serious Num At Risk
    11
    title
    9mg/kg NC525
  5. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    4
    serious Num At Risk
    4
    title
    13.5mg/kg NC525
  6. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
    id
    EG005
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    18mg/kg NC525
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Atrial flutter
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Pericardial effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Sinus bradycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Ear congestion
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Ear pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Hypoacusis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Dry eye
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Extrasystoles
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Conjunctival haemorrhage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Lower gastrointestinal haemorrhage
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Oesophagitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Upper gastrointestinal haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    term
    Disease progression
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    term
    Pyrexia
time Frame
From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).

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Preserved source evidence · Not medical advice