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NCT03881488 · ADVERSE EVENTS

Adverse events

Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies · Source last updated 2026-10-09

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CTX-471 Monotherapy 0.1 mg/kg

0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks

1 / 32 / 33 / 3
CTX-471 Monotherapy 0.3 mg/kg

0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks

11 / 3333 / 3322 / 33
CTX-471 Monotherapy 0.6 mg/kg

0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks

17 / 3636 / 3630 / 36
CTX-471 Monotherapy 1.2 mg/kg

1.2 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks

3 / 77 / 75 / 7
CTX-471 Combination 0.1 mg/kg

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

2 / 33 / 32 / 3
CTX-471 Combination 0.3 mg/kg

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

2 / 98 / 95 / 9
CTX-471 Combination 0.6 mg/kg

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

4 / 99 / 95 / 9

Group identifiers: EG000: CTX-471 Monotherapy 0.1 mg/kg · EG001: CTX-471 Monotherapy 0.3 mg/kg · EG002: CTX-471 Monotherapy 0.6 mg/kg · EG003: CTX-471 Monotherapy 1.2 mg/kg · EG004: CTX-471 Combination 0.1 mg/kg · EG005: CTX-471 Combination 0.3 mg/kg · EG006: CTX-471 Combination 0.6 mg/kg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Hypoxia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pulmonary embolism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Aspiration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Bronchostenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Dyspnoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Haemoptysis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Obstructive airways disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pharyngeal stenosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pneumonia aspiration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pneumonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pneumothorax
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Respiratory failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      9
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Oedema peripheral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Catheter site oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Catheter site pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Face oedema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Feeling abnormal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Impaired healing
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Infusion site extravasation
Complete source fields
event Groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      9
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Oedema peripheral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Catheter site oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Catheter site pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Face oedema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Feeling abnormal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Impaired healing
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Infusion site extravasation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Hypoxia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pulmonary embolism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Aspiration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Bronchostenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Dyspnoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Haemoptysis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Obstructive airways disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pharyngeal stenosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pneumonia aspiration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pneumonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Pneumothorax
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. 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

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Preserved source evidence · Not medical advice