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NCT04420689 · ADVERSE EVENTS

Adverse events

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery · Source last updated 2025-05-08

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
28 (+5) days
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Defining 100mg

This group of the study will receive 100mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.

0 / 32 / 30 / 3
Dose Defining 200mg

This group of the study will receive 200mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.

0 / 31 / 30 / 3
Dose Defining 400mg

This group of the study will receive 400mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.

0 / 31 / 30 / 3
Dose Defining 500mg

This group of the study will receive 500mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.

0 / 30 / 30 / 3
Dose Defining 600mg

This group of the study will receive 600mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.

1 / 32 / 30 / 3
Dose Timing 1-3hrs

This group of the study will receive ALM-488 1-3 hours before surgery. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.usly administered.

0 / 63 / 60 / 6
Dose Timing 3-5hrs

This group of the study will receive ALM-488 3-5 hours before surgery. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.usly administered.

1 / 63 / 60 / 6

Group identifiers: EG000: Dose Defining 100mg · EG001: Dose Defining 200mg · EG002: Dose Defining 400mg · EG003: Dose Defining 500mg · EG004: Dose Defining 600mg · EG005: Dose Timing 1-3hrs · EG006: Dose Timing 3-5hrs

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
    Infections and infestations
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    neck infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Dental Infection

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    salivary gland fistula
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    chills
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    non cardiac chest pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    covid-19
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    urinary tract infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    confusion
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    nerve injury
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    seroma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    pain in extremity
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    facial paresis
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    This group of the study will receive 100mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Defining 100mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    This group of the study will receive 200mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Defining 200mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    This group of the study will receive 400mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Defining 400mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    This group of the study will receive 500mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Defining 500mg
  5. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    This group of the study will receive 600mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Dose Defining 600mg
  6. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    This group of the study will receive ALM-488 1-3 hours before surgery. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.usly administered.
    id
    EG005
    other Num Affected
    3
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Dose Timing 1-3hrs
  7. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    This group of the study will receive ALM-488 3-5 hours before surgery. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.usly administered.
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Dose Timing 3-5hrs
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    salivary gland fistula
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    chills
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    non cardiac chest pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    covid-19
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    urinary tract infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    confusion
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    nerve injury
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    seroma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    pain in extremity
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    facial paresis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    neck infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Dental Infection
time Frame
28 (+5) days

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Preserved source evidence · Not medical advice