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NCT05259696 · ADVERSE EVENTS

Adverse events

Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01) · Source last updated 2025-08-20

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
Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Other-event reporting threshold
5%

Adverse Events were graded using CTCAE v5.0

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
E-602 1 mg/kg

Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.

3 / 55 / 55 / 5
E-602 3 mg/kg

Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.

1 / 44 / 41 / 4
E-602 10 mg/kg

Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.

1 / 98 / 97 / 9
E-602 20 mg/kg

Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.

6 / 1515 / 159 / 15
E-602 30 mg/kg

Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.

5 / 1515 / 156 / 15
E-602 20 mg/kg in Combination With Cemiplimab

Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.

5 / 2120 / 215 / 21

Group identifiers: EG000: E-602 1 mg/kg · EG001: E-602 3 mg/kg · EG002: E-602 10 mg/kg · EG003: E-602 20 mg/kg · EG004: E-602 30 mg/kg · EG005: E-602 20 mg/kg in Combination With Cemiplimab

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
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Cardiac failure congestive
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Large intestine perforation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Ascites
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Large intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Acute hepatic failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Anorectal infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    COVID-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Enterocolitis infectious
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Pneumonia klebsiella

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
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      21
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      21
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      21
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      21
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      21
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      21
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      21
    term
    Upper respiratory infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      21
    term
    Infusion related reaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Aspartate aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Blood alkaline phosphatase increased
Complete source fields
description
Adverse Events were graded using CTCAE v5.0
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    5
    description
    Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    E-602 1 mg/kg
  2. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    E-602 3 mg/kg
  3. deaths Num Affected
    7
    deaths Num At Risk
    9
    description
    Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    1
    serious Num At Risk
    9
    title
    E-602 10 mg/kg
  4. deaths Num Affected
    9
    deaths Num At Risk
    15
    description
    Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.
    id
    EG003
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    6
    serious Num At Risk
    15
    title
    E-602 20 mg/kg
  5. deaths Num Affected
    6
    deaths Num At Risk
    15
    description
    Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.
    id
    EG004
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    5
    serious Num At Risk
    15
    title
    E-602 30 mg/kg
  6. deaths Num Affected
    5
    deaths Num At Risk
    21
    description
    Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.
    id
    EG005
    other Num Affected
    20
    other Num At Risk
    21
    serious Num Affected
    5
    serious Num At Risk
    21
    title
    E-602 20 mg/kg in Combination With Cemiplimab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      21
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      21
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      21
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      21
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      21
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      21
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      21
    term
    Upper respiratory infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      21
    term
    Infusion related reaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Aspartate aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Blood alkaline phosphatase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Cardiac failure congestive
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Large intestine perforation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Ascites
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Large intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      21
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Acute hepatic failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Anorectal infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    COVID-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Enterocolitis infectious
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      21
    term
    Pneumonia klebsiella
time Frame
Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.

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Preserved source evidence · Not medical advice