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NCT02052778 · ADVERSE EVENTS

Adverse events

A Study of TAS-120 in Patients With Advanced Solid Tumors · Source last updated 2025-03-27

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
From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
Other-event reporting threshold
5%

Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Dose Escalation: QOD Dosing: 8 mg

Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 8 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

1 / 66 / 60 / 6
Phase 1: Dose Escalation: QOD Dosing: 16 mg

Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 16 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

0 / 33 / 30 / 3
Phase 1: Dose Escalation: QOD Dosing: 24 mg

Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

1 / 33 / 30 / 3
Phase 1: Dose Escalation: QOD Dosing: 36 mg

Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 36 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

1 / 33 / 30 / 3
Phase 1: Dose Escalation: QOD Dosing: 56 mg

Participants with FGF/FGFR gene abnormalities received orally TAS-120 56 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

1 / 33 / 30 / 3
Phase 1: Dose Escalation: QOD Dosing: 80 mg

Participants with FGF/FGFR gene abnormalities received orally TAS-120 80 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

2 / 55 / 50 / 5
Phase 1: Dose Escalation: QOD Dosing: 120 mg

Participants with FGF/FGFR gene abnormalities received orally TAS-120 120 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

4 / 44 / 41 / 4
Phase 1: Dose Escalation: QOD Dosing: 160 mg

Participants with FGF/FGFR gene abnormalities received orally TAS-120 160 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

7 / 88 / 80 / 8
Phase 1: Dose Escalation: QOD Dosing: 200 mg

Participants with FGF/FGFR gene abnormalities received orally TAS-120 200 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

4 / 77 / 72 / 7
Phase 1: Dose Escalation: QD Dosing: 4 mg

Participants with or without FGF/FGFR gene abnormalities received a dose between 4 mg orally once daily (QD) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

0 / 44 / 40 / 4
Phase 1: Dose Escalation: QD Dosing: 8 mg

Participants with or without FGF/FGFR gene abnormalities received a dose between 8 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

1 / 55 / 50 / 5
Phase 1: Dose Escalation: QD Dosing: 16 mg

Participants with or without FGF/FGFR gene abnormalities received a dose between 16 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

9 / 1414 / 142 / 14
Phase 1: Dose Escalation: QD Dosing: 20 mg

Participants with or without FGF/FGFR gene abnormalities received a dose between 20 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

3 / 77 / 71 / 7
Phase 1: Dose Escalation: QD Dosing: 24 mg

Participants with or without FGF/FGFR gene abnormalities received a dose between 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

6 / 1414 / 141 / 14
Phase 1: Dose Expansion Cohort 1

Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum exposure: 33.5 months).

27 / 5757 / 5740 / 57
Phase 1: Dose Expansion: Cohort 2

Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum exposure: 28.5 months).

13 / 3434 / 3422 / 34
Phase 1: Dose Expansion: Cohort 3

Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum exposure: 9.6 months).

10 / 1515 / 1512 / 15
Phase 1: Dose Expansion: Cohort 4

Participants with breast or gastric cancer with harboring FGFR2 amplification received TAS-120 20 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum exposure: 5.5 months).

9 / 1313 / 1311 / 13
Phase 1: Dose Expansion: Cohort 5

Participants with tumor types harboring FGFR gene fusions or activating mutations received TAS-120 20 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum exposure: 42.5 months).

13 / 2423 / 2415 / 24
Phase 1: Dose Expansion: Cohort 6

Participants who were not included in Cohorts 1 to 5 received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum exposure: 11 months).

14 / 2726 / 2717 / 27
Phase 1: Dose Expansion: Sub-cohort 2

Participants with other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum exposure: 45.5 months).

0 / 88 / 81 / 8
Phase 1: Dose Expansion: Sub-cohort 1

Participants with iCCA who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum exposure: 28 months).

0 / 1919 / 199 / 19
Phase 2

Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death (maximum duration: 30 months).

42 / 103103 / 10358 / 103

Group identifiers: EG000: Phase 1: Dose Escalation: QOD Dosing: 8 mg · EG001: Phase 1: Dose Escalation: QOD Dosing: 16 mg · EG002: Phase 1: Dose Escalation: QOD Dosing: 24 mg · EG003: Phase 1: Dose Escalation: QOD Dosing: 36 mg · EG004: Phase 1: Dose Escalation: QOD Dosing: 56 mg · EG005: Phase 1: Dose Escalation: QOD Dosing: 80 mg · EG006: Phase 1: Dose Escalation: QOD Dosing: 120 mg · EG007: Phase 1: Dose Escalation: QOD Dosing: 160 mg · EG008: Phase 1: Dose Escalation: QOD Dosing: 200 mg · EG009: Phase 1: Dose Escalation: QD Dosing: 4 mg · EG010: Phase 1: Dose Escalation: QD Dosing: 8 mg · EG011: Phase 1: Dose Escalation: QD Dosing: 16 mg · EG012: Phase 1: Dose Escalation: QD Dosing: 20 mg · EG013: Phase 1: Dose Escalation: QD Dosing: 24 mg · EG014: Phase 1: Dose Expansion Cohort 1 · EG015: Phase 1: Dose Expansion: Cohort 2 · EG016: Phase 1: Dose Expansion: Cohort 3 · EG017: Phase 1: Dose Expansion: Cohort 4 · EG018: Phase 1: Dose Expansion: Cohort 5 · EG019: Phase 1: Dose Expansion: Cohort 6 · EG020: Phase 1: Dose Expansion: Sub-cohort 2 · EG021: Phase 1: Dose Expansion: Sub-cohort 1 · EG022: Phase 2

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 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ventricular tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ocular ischaemic syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Papilloedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Retinal detachment
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      8
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Colitis

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 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
      num Events
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      8
      num Events
      8
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Lymphadenopathy mediastinal
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Hypoacusis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cataract
Complete source fields
description
Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 8 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Phase 1: Dose Escalation: QOD Dosing: 8 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 16 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Phase 1: Dose Escalation: QOD Dosing: 16 mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1: Dose Escalation: QOD Dosing: 24 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 36 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1: Dose Escalation: QOD Dosing: 36 mg
  5. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 56 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1: Dose Escalation: QOD Dosing: 56 mg
  6. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 80 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase 1: Dose Escalation: QOD Dosing: 80 mg
  7. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 120 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    4
    serious Num At Risk
    4
    title
    Phase 1: Dose Escalation: QOD Dosing: 120 mg
  8. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 160 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG007
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    7
    serious Num At Risk
    8
    title
    Phase 1: Dose Escalation: QOD Dosing: 160 mg
  9. deaths Num Affected
    2
    deaths Num At Risk
    7
    description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 200 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG008
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Phase 1: Dose Escalation: QOD Dosing: 200 mg
  10. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants with or without FGF/FGFR gene abnormalities received a dose between 4 mg orally once daily (QD) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG009
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Phase 1: Dose Escalation: QD Dosing: 4 mg
  11. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Participants with or without FGF/FGFR gene abnormalities received a dose between 8 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG010
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Phase 1: Dose Escalation: QD Dosing: 8 mg
  12. deaths Num Affected
    2
    deaths Num At Risk
    14
    description
    Participants with or without FGF/FGFR gene abnormalities received a dose between 16 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG011
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    9
    serious Num At Risk
    14
    title
    Phase 1: Dose Escalation: QD Dosing: 16 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
      num Events
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      8
      num Events
      8
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Lymphadenopathy mediastinal
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Hypoacusis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cataract
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ventricular tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ocular ischaemic syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Papilloedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Retinal detachment
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      8
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0, 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Colitis
time Frame
From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2

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Preserved source evidence · Not medical advice