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NCT02371369 · ADVERSE EVENTS

Adverse events

Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) · Source last updated 2022-05-11

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 monitored throughout the study from the time the participant signed the informed consent form to 28 days after the final treatment dose, up to 71 months.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pexidartinib (Part 1)

Participants received blinded treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration

8 / 6160 / 610 / 61
Placebo (Part 1)

Participants received blinded treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching pexidartinib capsule for oral administration

1 / 5955 / 590 / 59
Pexidartinib (Parts 1 and 2)

Participants received pexidartinib in Part 1 and in Part 2 at their prescribed dose Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration

12 / 6161 / 610 / 61
Placebo (Part 1), Crossover Pexidartinib (Part 2)

Participants received placebo in Part 1 and pexidartinib in Part 2 at their prescribed dose Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration Placebo: Placebo capsule matching pexidartinib capsule for oral administration

9 / 3030 / 301 / 30
All Pexidartinib Treated

All participants who received pexidartinib in Part 1 and Part 2 (placebo crossed over to pexidartinib)

21 / 9191 / 911 / 91

Group identifiers: EG000: Pexidartinib (Part 1) · EG001: Placebo (Part 1) · EG002: Pexidartinib (Parts 1 and 2) · EG003: Placebo (Part 1), Crossover Pexidartinib (Part 2) · EG004: All Pexidartinib Treated

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
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Transaminases increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Liver function test abnormal
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Hepatic enzyme abnormal
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Adenosquamous carcinoma of the cervix
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Rectal adenocarcinoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      91
    term
    Endometrial cancer
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Squamous cell carcinoma of skin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Asthma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Migraine
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Local swelling

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
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      61
      num Events
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      59
      num Events
      6
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      61
      num Events
      24
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      30
      num Events
      21
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      91
      num Events
      45
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      91
      num Events
      2
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      61
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      91
      num Events
      9
    term
    Tumor pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      61
      num Events
      49
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      59
      num Events
      26
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      61
      num Events
      57
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      30
      num Events
      13
    5. group Id
      EG004
      num Affected
      43
      num At Risk
      91
      num Events
      70
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      61
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      61
      num Events
      11
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      30
      num Events
      13
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      91
      num Events
      24
    term
    Face oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      61
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
      num Events
      2
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      61
      num Events
      18
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      30
      num Events
      11
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      91
      num Events
      29
    term
    Oedema peripheral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
      num Events
      5
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      61
      num Events
      16
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      30
      num Events
      18
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      91
      num Events
      34
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      61
      num Events
      8
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      30
      num Events
      6
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      91
      num Events
      14
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      61
      num Events
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      91
      num Events
      7
    term
    Influenza like illness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      91
      num Events
      3
    term
    Chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      91
      num Events
      4
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      61
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      4
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      91
      num Events
      8
    term
    Insomnia
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    61
    description
    Participants received blinded treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
    id
    EG000
    other Num Affected
    60
    other Num At Risk
    61
    serious Num Affected
    8
    serious Num At Risk
    61
    title
    Pexidartinib (Part 1)
  2. deaths Num Affected
    0
    deaths Num At Risk
    59
    description
    Participants received blinded treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching pexidartinib capsule for oral administration
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    59
    serious Num Affected
    1
    serious Num At Risk
    59
    title
    Placebo (Part 1)
  3. deaths Num Affected
    0
    deaths Num At Risk
    61
    description
    Participants received pexidartinib in Part 1 and in Part 2 at their prescribed dose Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
    id
    EG002
    other Num Affected
    61
    other Num At Risk
    61
    serious Num Affected
    12
    serious Num At Risk
    61
    title
    Pexidartinib (Parts 1 and 2)
  4. deaths Num Affected
    1
    deaths Num At Risk
    30
    description
    Participants received placebo in Part 1 and pexidartinib in Part 2 at their prescribed dose Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration Placebo: Placebo capsule matching pexidartinib capsule for oral administration
    id
    EG003
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    9
    serious Num At Risk
    30
    title
    Placebo (Part 1), Crossover Pexidartinib (Part 2)
  5. deaths Num Affected
    1
    deaths Num At Risk
    91
    description
    All participants who received pexidartinib in Part 1 and Part 2 (placebo crossed over to pexidartinib)
    id
    EG004
    other Num Affected
    91
    other Num At Risk
    91
    serious Num Affected
    21
    serious Num At Risk
    91
    title
    All Pexidartinib Treated
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      61
      num Events
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      59
      num Events
      6
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      61
      num Events
      24
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      30
      num Events
      21
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      91
      num Events
      45
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      91
      num Events
      2
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      61
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      91
      num Events
      9
    term
    Tumor pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      61
      num Events
      49
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      59
      num Events
      26
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      61
      num Events
      57
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      30
      num Events
      13
    5. group Id
      EG004
      num Affected
      43
      num At Risk
      91
      num Events
      70
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      61
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      61
      num Events
      11
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      30
      num Events
      13
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      91
      num Events
      24
    term
    Face oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      61
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
      num Events
      2
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      61
      num Events
      18
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      30
      num Events
      11
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      91
      num Events
      29
    term
    Oedema peripheral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
      num Events
      5
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      61
      num Events
      16
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      30
      num Events
      18
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      91
      num Events
      34
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      61
      num Events
      8
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      30
      num Events
      6
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      91
      num Events
      14
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      61
      num Events
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      91
      num Events
      7
    term
    Influenza like illness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      91
      num Events
      3
    term
    Chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      91
      num Events
      4
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      61
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      4
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      91
      num Events
      8
    term
    Insomnia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Transaminases increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Liver function test abnormal
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Hepatic enzyme abnormal
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Adenosquamous carcinoma of the cervix
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Rectal adenocarcinoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      91
    term
    Endometrial cancer
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Squamous cell carcinoma of skin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Asthma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Migraine
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      91
    term
    Local swelling
time Frame
Adverse events were monitored throughout the study from the time the participant signed the informed consent form to 28 days after the final treatment dose, up to 71 months.

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Preserved source evidence · Not medical advice