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NCT03260023 · ADVERSE EVENTS

Adverse events

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers · Source last updated 2026-02-05

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
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I - TG4001 5x10e6 Pfu + Avelumab

Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

1 / 33 / 31 / 3
Phase I - TG4001 5x10e7 Pfu + Avelumab

Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

4 / 66 / 60 / 6
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab

Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

18 / 3434 / 3412 / 34
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab

Participants without liver metastasis received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

16 / 4646 / 467 / 46
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab

Participants without liver metastasis received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

18 / 4443 / 445 / 44
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab

Participants with liver metastasis received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

2 / 55 / 51 / 5
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab

Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

0 / 44 / 40 / 4

Group identifiers: EG000: Phase I - TG4001 5x10e6 Pfu + Avelumab · EG001: Phase I - TG4001 5x10e7 Pfu + Avelumab · EG002: Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab · EG003: Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab · EG004: Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab · EG005: Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab · EG006: Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab

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 Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Cardiac tamponade
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Vertigo
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hypercalcaemia of malignancy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Anal fistula
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Obstruction gastric
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pancreatitis acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pneumoperitoneum
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Rectal haemorrhage

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 Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      34
      num Events
      26
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      46
      num Events
      43
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      44
      num Events
      29
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
      num Events
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Antiphospholipid syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Haematotoxicity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Iron deficiency anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      2
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      46
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Lymphadenopathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      4
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      46
      num Events
      15
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Lymphopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      46
      num Events
      12
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      44
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Cardiac valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Intracardiac thrombus
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase I - TG4001 5x10e6 Pfu + Avelumab
  2. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Phase I - TG4001 5x10e7 Pfu + Avelumab
  3. deaths Num Affected
    12
    deaths Num At Risk
    34
    description
    Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
    id
    EG002
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    18
    serious Num At Risk
    34
    title
    Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
  4. deaths Num Affected
    7
    deaths Num At Risk
    46
    description
    Participants without liver metastasis received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
    id
    EG003
    other Num Affected
    46
    other Num At Risk
    46
    serious Num Affected
    16
    serious Num At Risk
    46
    title
    Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
  5. deaths Num Affected
    5
    deaths Num At Risk
    44
    description
    Participants without liver metastasis received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
    id
    EG004
    other Num Affected
    43
    other Num At Risk
    44
    serious Num Affected
    18
    serious Num At Risk
    44
    title
    Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
  6. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Participants with liver metastasis received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab
  7. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      34
      num Events
      26
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      46
      num Events
      43
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      44
      num Events
      29
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
      num Events
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Antiphospholipid syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Haematotoxicity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Iron deficiency anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      2
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      46
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Lymphadenopathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      4
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      46
      num Events
      15
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Lymphopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      46
      num Events
      12
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      44
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Cardiac valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Intracardiac thrombus
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Cardiac tamponade
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Vertigo
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hypercalcaemia of malignancy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Anal fistula
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Obstruction gastric
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pancreatitis acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pneumoperitoneum
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Rectal haemorrhage
time Frame
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.

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