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NCT02564900 · ADVERSE EVENTS

Adverse events

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors · Source last updated 2024-01-22

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
Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
Other-event reporting threshold
5%

TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Escalation: Cohort 1, 0.8 mg/kg

Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).

0 / 33 / 30 / 3
Dose Escalation: Cohort 2, 1.6 mg/kg

Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).

0 / 33 / 30 / 3
Dose Escalation: Cohort 3, 3.2 mg/kg

Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).

0 / 33 / 30 / 3
Dose Escalation: Cohort 4, 5.4 mg/kg

Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

1 / 66 / 60 / 6
Dose Escalation: Cohort 5, 6.4 mg/kg

Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

1 / 66 / 60 / 6
Dose Escalation: Cohort 6, 8.0 mg/kg

Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).

1 / 66 / 60 / 6
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg

Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

11 / 5050 / 503 / 50
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg

Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

17 / 6666 / 661 / 66
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg

Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

3 / 2120 / 210 / 21
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg

Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

12 / 3333 / 330 / 33
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg

Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

4 / 1919 / 191 / 19
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg

Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

7 / 2525 / 251 / 25
Dose Expansion: HER2-expressing Other Solid Tumors

Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

18 / 5959 / 595 / 59

Group identifiers: EG000: Dose Escalation: Cohort 1, 0.8 mg/kg · EG001: Dose Escalation: Cohort 2, 1.6 mg/kg · EG002: Dose Escalation: Cohort 3, 3.2 mg/kg · EG003: Dose Escalation: Cohort 4, 5.4 mg/kg · EG004: Dose Escalation: Cohort 5, 6.4 mg/kg · EG005: Dose Escalation: Cohort 6, 8.0 mg/kg · EG006: Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg · EG007: Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg · EG008: Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg · EG009: Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg · EG010: Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg · EG011: Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg · EG012: Dose Expansion: HER2-expressing Other Solid Tumors

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
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Bacteraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Influenza
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Osteomyelitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Peritonitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Postoperative wound infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Pyelonephritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Streptococcal bacteraemia

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
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      25
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Upper respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      25
    term
    Cystitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      25
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      25
    term
    Lung infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Urinary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Conjunctivitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Gastroenteritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      25
    term
    Angular cheilitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Bronchitis
Complete source fields
description
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Escalation: Cohort 1, 0.8 mg/kg
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Escalation: Cohort 2, 1.6 mg/kg
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Escalation: Cohort 3, 3.2 mg/kg
  4. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Dose Escalation: Cohort 4, 5.4 mg/kg
  5. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG004
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Dose Escalation: Cohort 5, 6.4 mg/kg
  6. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG005
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Dose Escalation: Cohort 6, 8.0 mg/kg
  7. deaths Num Affected
    3
    deaths Num At Risk
    50
    description
    Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG006
    other Num Affected
    50
    other Num At Risk
    50
    serious Num Affected
    11
    serious Num At Risk
    50
    title
    Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
  8. deaths Num Affected
    1
    deaths Num At Risk
    66
    description
    Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG007
    other Num Affected
    66
    other Num At Risk
    66
    serious Num Affected
    17
    serious Num At Risk
    66
    title
    Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
  9. deaths Num Affected
    0
    deaths Num At Risk
    21
    description
    Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG008
    other Num Affected
    20
    other Num At Risk
    21
    serious Num Affected
    3
    serious Num At Risk
    21
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
  10. deaths Num Affected
    0
    deaths Num At Risk
    33
    description
    Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG009
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    12
    serious Num At Risk
    33
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
  11. deaths Num Affected
    1
    deaths Num At Risk
    19
    description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG010
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    4
    serious Num At Risk
    19
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
  12. deaths Num Affected
    1
    deaths Num At Risk
    25
    description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    EG011
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    7
    serious Num At Risk
    25
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      25
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Upper respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      25
    term
    Cystitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      25
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      25
    term
    Lung infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Urinary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Conjunctivitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Gastroenteritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      25
    term
    Angular cheilitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Bronchitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      25
    term
    Bacteraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Influenza
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Osteomyelitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Peritonitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Postoperative wound infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Pyelonephritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      50
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      66
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      21
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      33
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      19
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      25
    term
    Streptococcal bacteraemia
time Frame
Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.

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Preserved source evidence · Not medical advice