NCT05787496 · ADVERSE EVENTS
Adverse events
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%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| 2mg/kg NC525 | 3 / 3 | 3 / 3 | 3 / 3 |
| 2.5mg/kg NC525 | 2 / 4 | 4 / 4 | 4 / 4 |
| 4.5mg/kg NC525 | 2 / 3 | 3 / 3 | 3 / 3 |
| 9mg/kg NC525 | 9 / 11 | 11 / 11 | 9 / 11 |
| 13.5mg/kg NC525 | 4 / 4 | 4 / 4 | 2 / 4 |
| 18mg/kg NC525 | 3 / 3 | 3 / 3 | 2 / 3 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Leukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Extrasystoles
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Conjunctival haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Gastrointestinal haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Lower gastrointestinal haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Oesophagitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Upper gastrointestinal haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Disease progression
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Pyrexia
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Atrial flutter
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Pericardial effusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Sinus bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Sinus tachycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Ear congestion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Ear pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Hypoacusis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Dry eye
Complete source fields
- event Groups
- 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
- 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
- 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
- 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
- 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
- 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
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Atrial flutter
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Pericardial effusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Sinus bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Sinus tachycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Ear congestion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Ear pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Hypoacusis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Dry eye
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Leukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Extrasystoles
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Conjunctival haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Gastrointestinal haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Lower gastrointestinal haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Oesophagitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Upper gastrointestinal haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 3
- term
- Disease progression
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 3
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- 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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