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NCT02711345 · ADVERSE EVENTS

Adverse events

A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers. · Source last updated 2019-09-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse events were evaluated from screening until at least 30 days after the discontinuation of study treatment (Up to 2.8 years)
Other-event reporting threshold
5%

The Safety Set included all participants who had received at least one dose of LTT462.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
LTT462 45 mg QD

Participants received 45 mg LTT462 QD as oral capsules.

1 / 22 / 21 / 2
LTT462 100 mg QD

Participants received 100 mg LTT462 QD as oral capsules.

0 / 33 / 30 / 3
LTT462 150 mg QD

Participants received 150 mg LTT462 QD as oral capsules.

3 / 66 / 60 / 6
LTT462 200 mg QD

Participants received 200 mg LTT462 QD as oral capsules.

1 / 44 / 40 / 4
LTT462 300 mg QD

Participants received 300 mg LTT462 QD as oral capsules.

5 / 88 / 82 / 8
LTT462 400 mg QD

Participants received 400 mg LTT462 QD as oral capsules.

1 / 66 / 61 / 6
LTT462 450 mg QD

Participants received 450 mg LTT462 QD as oral capsules.

8 / 1212 / 121 / 12
LTT462 600 mg QD

Participants received 450 mg LTT462 QD as oral capsules.

4 / 65 / 61 / 6
All QD Participants

Participants received 45 to 600 mg LTT462 QD as oral capsules.

23 / 4746 / 476 / 47
LTT462 150 mg BID

Participants received 150 mg LTT462 BID as oral capsules.

3 / 66 / 61 / 6
LTT462 200 mg BID

Participants received 200 mg LTT462 BID as oral capsules.

5 / 1212 / 120 / 12
All BID Participants

Participants received 150 and 200 mg LTT462 BID as oral capsules.

8 / 1818 / 181 / 18

Group identifiers: EG000: LTT462 45 mg QD · EG001: LTT462 100 mg QD · EG002: LTT462 150 mg QD · EG003: LTT462 200 mg QD · EG004: LTT462 300 mg QD · EG005: LTT462 400 mg QD · EG006: LTT462 450 mg QD · EG007: LTT462 600 mg QD · EG008: All QD Participants · EG009: LTT462 150 mg BID · EG010: LTT462 200 mg BID · EG011: All BID Participants

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Cardio-respiratory arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Retinopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      18
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      18
    term
    Gastrointestinal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      18
    term
    Nausea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      18
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      18
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      18
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      18
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Aortic valve incompetence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Cyanosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Tricuspid valve incompetence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Goitre
Complete source fields
description
The Safety Set included all participants who had received at least one dose of LTT462.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Participants received 45 mg LTT462 QD as oral capsules.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    LTT462 45 mg QD
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants received 100 mg LTT462 QD as oral capsules.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    LTT462 100 mg QD
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants received 150 mg LTT462 QD as oral capsules.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    LTT462 150 mg QD
  4. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants received 200 mg LTT462 QD as oral capsules.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    LTT462 200 mg QD
  5. deaths Num Affected
    2
    deaths Num At Risk
    8
    description
    Participants received 300 mg LTT462 QD as oral capsules.
    id
    EG004
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    5
    serious Num At Risk
    8
    title
    LTT462 300 mg QD
  6. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants received 400 mg LTT462 QD as oral capsules.
    id
    EG005
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    LTT462 400 mg QD
  7. deaths Num Affected
    1
    deaths Num At Risk
    12
    description
    Participants received 450 mg LTT462 QD as oral capsules.
    id
    EG006
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    8
    serious Num At Risk
    12
    title
    LTT462 450 mg QD
  8. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants received 450 mg LTT462 QD as oral capsules.
    id
    EG007
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    LTT462 600 mg QD
  9. deaths Num Affected
    6
    deaths Num At Risk
    47
    description
    Participants received 45 to 600 mg LTT462 QD as oral capsules.
    id
    EG008
    other Num Affected
    46
    other Num At Risk
    47
    serious Num Affected
    23
    serious Num At Risk
    47
    title
    All QD Participants
  10. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants received 150 mg LTT462 BID as oral capsules.
    id
    EG009
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    LTT462 150 mg BID
  11. deaths Num Affected
    0
    deaths Num At Risk
    12
    description
    Participants received 200 mg LTT462 BID as oral capsules.
    id
    EG010
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    5
    serious Num At Risk
    12
    title
    LTT462 200 mg BID
  12. deaths Num Affected
    1
    deaths Num At Risk
    18
    description
    Participants received 150 and 200 mg LTT462 BID as oral capsules.
    id
    EG011
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    8
    serious Num At Risk
    18
    title
    All BID Participants
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      18
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      18
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      18
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      18
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Aortic valve incompetence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Cyanosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Tricuspid valve incompetence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Goitre
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Cardio-respiratory arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Retinopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      18
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      18
    term
    Gastrointestinal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      18
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      47
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      12
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      18
    term
    Nausea
time Frame
Adverse events were evaluated from screening until at least 30 days after the discontinuation of study treatment (Up to 2.8 years)

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Preserved source evidence · Not medical advice