NCT03881488 · 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 the signing of the informed consent form through 60 days after the last dose of CTX-471 (average of 27 weeks) for the monotherapy arms, from the signing of the informed consent form through 90 days after the last dose of pembrolizumab (average of 28 weeks) for the combination arms
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| CTX-471 Monotherapy 0.1 mg/kg | 1 / 3 | 2 / 3 | 3 / 3 |
| CTX-471 Monotherapy 0.3 mg/kg | 11 / 33 | 33 / 33 | 22 / 33 |
| CTX-471 Monotherapy 0.6 mg/kg | 17 / 36 | 36 / 36 | 30 / 36 |
| CTX-471 Monotherapy 1.2 mg/kg | 3 / 7 | 7 / 7 | 5 / 7 |
| CTX-471 Combination 0.1 mg/kg | 2 / 3 | 3 / 3 | 2 / 3 |
| CTX-471 Combination 0.3 mg/kg | 2 / 9 | 8 / 9 | 5 / 9 |
| CTX-471 Combination 0.6 mg/kg | 4 / 9 | 9 / 9 | 5 / 9 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Hypoxia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pulmonary embolism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Aspiration
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Bronchostenosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Dyspnoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Haemoptysis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Obstructive airways disorder
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pharyngeal stenosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pneumonia aspiration
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pneumonitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pneumothorax
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Respiratory failure
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 6
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 4
- num At Risk
- 9
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 3
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Oedema peripheral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pyrexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 9
- term
- Asthenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 9
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Catheter site oedema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Catheter site pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 9
- term
- Face oedema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 9
- term
- Feeling abnormal
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Impaired healing
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Infusion site extravasation
Complete source fields
- event Groups
- deaths Num Affected
- 3
- deaths Num At Risk
- 3
- description
- 0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
- id
- EG000
- other Num Affected
- 2
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- CTX-471 Monotherapy 0.1 mg/kg
- deaths Num Affected
- 22
- deaths Num At Risk
- 33
- description
- 0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
- id
- EG001
- other Num Affected
- 33
- other Num At Risk
- 33
- serious Num Affected
- 11
- serious Num At Risk
- 33
- title
- CTX-471 Monotherapy 0.3 mg/kg
- deaths Num Affected
- 30
- deaths Num At Risk
- 36
- description
- 0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
- id
- EG002
- other Num Affected
- 36
- other Num At Risk
- 36
- serious Num Affected
- 17
- serious Num At Risk
- 36
- title
- CTX-471 Monotherapy 0.6 mg/kg
- deaths Num Affected
- 5
- deaths Num At Risk
- 7
- description
- 1.2 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
- id
- EG003
- other Num Affected
- 7
- other Num At Risk
- 7
- serious Num Affected
- 3
- serious Num At Risk
- 7
- title
- CTX-471 Monotherapy 1.2 mg/kg
- deaths Num Affected
- 2
- deaths Num At Risk
- 3
- description
- 0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
- id
- EG004
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 2
- serious Num At Risk
- 3
- title
- CTX-471 Combination 0.1 mg/kg
- deaths Num Affected
- 5
- deaths Num At Risk
- 9
- description
- 0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
- id
- EG005
- other Num Affected
- 8
- other Num At Risk
- 9
- serious Num Affected
- 2
- serious Num At Risk
- 9
- title
- CTX-471 Combination 0.3 mg/kg
- deaths Num Affected
- 5
- deaths Num At Risk
- 9
- description
- 0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
- id
- EG006
- other Num Affected
- 9
- other Num At Risk
- 9
- serious Num Affected
- 4
- serious Num At Risk
- 9
- title
- CTX-471 Combination 0.6 mg/kg
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 6
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 4
- num At Risk
- 9
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 3
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Oedema peripheral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pyrexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 9
- term
- Asthenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 9
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Catheter site oedema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Catheter site pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 9
- term
- Face oedema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 9
- term
- Feeling abnormal
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Impaired healing
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Infusion site extravasation
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Hypoxia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pulmonary embolism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Aspiration
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Bronchostenosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Dyspnoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Haemoptysis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Obstructive airways disorder
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pharyngeal stenosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pneumonia aspiration
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pneumonitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Pneumothorax
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 33
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 36
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 9
- term
- Respiratory failure
- time Frame
- From the signing of the informed consent form through 60 days after the last dose of CTX-471 (average of 27 weeks) for the monotherapy arms, from the signing of the informed consent form through 90 days after the last dose of pembrolizumab (average of 28 weeks) for the combination arms
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
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