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NCT00700336 · ADVERSE EVENTS

Adverse events

Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) · Source last updated 2021-07-20

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pemetrexed, Cisplatin, and CBP501: Phase 2

pemetrexed, cisplatin and CBP501 pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP. Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL. Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.

21 / 4028 / 401 / 40
Pemetrexed and Cisplatin: Phase 2

pemetrexed and cisplatin pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL. Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.

13 / 2315 / 231 / 23
Pemetrexed, Cisplatin, and CBP501: Phase 1

DL1: CBP501 16mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2

5 / 66 / 64 / 6

Group identifiers: EG000: Pemetrexed, Cisplatin, and CBP501: Phase 2 · EG001: Pemetrexed and Cisplatin: Phase 2 · EG002: Pemetrexed, Cisplatin, and CBP501: Phase 1

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Haemoglobin decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Hyponatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Malignant neoplasm progressed
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    renal failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    dyspnea

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
    term
    anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    term
    abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    term
    constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    term
    diarrhea
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    40
    description
    pemetrexed, cisplatin and CBP501 pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP. Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL. Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
    id
    EG000
    other Num Affected
    28
    other Num At Risk
    40
    serious Num Affected
    21
    serious Num At Risk
    40
    title
    Pemetrexed, Cisplatin, and CBP501: Phase 2
  2. deaths Num Affected
    1
    deaths Num At Risk
    23
    description
    pemetrexed and cisplatin pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL. Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    23
    serious Num Affected
    13
    serious Num At Risk
    23
    title
    Pemetrexed and Cisplatin: Phase 2
  3. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    DL1: CBP501 16mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Pemetrexed, Cisplatin, and CBP501: Phase 1
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
    term
    anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    term
    abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    term
    constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    term
    diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Haemoglobin decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Hyponatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Malignant neoplasm progressed
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    renal failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    dyspnea

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