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NCT05386550 · ADVERSE EVENTS

Adverse events

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) · Source last updated 2026-02-19

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
up to 22.7 months
Other-event reporting threshold
5%

SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Xevinapant + IMRT

Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

19 / 8281 / 829 / 82
Placebo + IMRT

Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

15 / 8381 / 8314 / 83

Group identifiers: EG000: Xevinapant + IMRT · EG001: Placebo + IMRT

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Mesenteric artery thrombosis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Oral pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Stomatitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Death
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Device related thrombosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Disease progression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    General physical health deterioration
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Abscess jaw
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Cellulitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    COVID-19
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Enteritis infectious

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      82
      num Events
      24
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      83
      num Events
      8
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      82
      num Events
      17
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      83
      num Events
      11
    term
    Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      82
      num Events
      13
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      83
      num Events
      22
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      82
      num Events
      23
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      83
      num Events
      30
    term
    Dry mouth
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      82
      num Events
      18
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      83
      num Events
      11
    term
    Dysphagia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      82
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      83
      num Events
      9
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
      num Events
      8
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      83
      num Events
      7
    term
    Odynophagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      82
      num Events
      29
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      83
      num Events
      19
    term
    Stomatitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
      num Events
      7
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      83
      num Events
      7
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      82
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      83
      num Events
      9
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      82
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      83
      num Events
      6
    term
    Localised oedema
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      82
      num Events
      12
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      83
      num Events
      12
    term
    Mucosal inflammation
Complete source fields
description
SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    82
    description
    Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
    id
    EG000
    other Num Affected
    81
    other Num At Risk
    82
    serious Num Affected
    19
    serious Num At Risk
    82
    title
    Xevinapant + IMRT
  2. deaths Num Affected
    14
    deaths Num At Risk
    83
    description
    Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
    id
    EG001
    other Num Affected
    81
    other Num At Risk
    83
    serious Num Affected
    15
    serious Num At Risk
    83
    title
    Placebo + IMRT
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      82
      num Events
      24
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      83
      num Events
      8
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      82
      num Events
      17
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      83
      num Events
      11
    term
    Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      82
      num Events
      13
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      83
      num Events
      22
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      82
      num Events
      23
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      83
      num Events
      30
    term
    Dry mouth
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      82
      num Events
      18
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      83
      num Events
      11
    term
    Dysphagia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      82
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      83
      num Events
      9
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
      num Events
      8
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      83
      num Events
      7
    term
    Odynophagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      82
      num Events
      29
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      83
      num Events
      19
    term
    Stomatitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
      num Events
      7
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      83
      num Events
      7
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      82
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      83
      num Events
      9
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      82
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      83
      num Events
      6
    term
    Localised oedema
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      82
      num Events
      12
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      83
      num Events
      12
    term
    Mucosal inflammation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Mesenteric artery thrombosis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Oral pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Stomatitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Death
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Device related thrombosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Disease progression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    General physical health deterioration
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Abscess jaw
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Cellulitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    COVID-19
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Enteritis infectious
time Frame
up to 22.7 months

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