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NCT02567656 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma · Source last updated 2020-01-13

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
24 months
Other-event reporting threshold
5%

Summary of Related Treatment Emergent Adverse Events - All Patients

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose escalation_Cohort 1_200 mg

RP6530 administered 200 mg orally twice a day.

0 / 44 / 40 / 4
Dose escalation_Cohort 2_400 mg

RP6530 administered 400 mg orally twice a day.

0 / 43 / 41 / 4
Dose escalation_Cohort 3_800 mg (Fasting)

RP6530 administered 800 mg orally twice a day under fasting condition

0 / 55 / 51 / 5
Dose escalation_Cohort 4_800 mg (Fed)

RP6530 administered 800 mg orally twice a day under fed condition

0 / 65 / 61 / 6
Dose expansion_PTCL_800 mg (Fasting)

RP6530 administered 800 mg orally twice a day under fasting condition

3 / 1911 / 193 / 19
Dose expansion_CTCL_800 mg (Fasting)

RP6530 administered 800 mg orally twice a day under fasting condition

3 / 2017 / 201 / 20

Group identifiers: EG000: Dose escalation_Cohort 1_200 mg · EG001: Dose escalation_Cohort 2_400 mg · EG002: Dose escalation_Cohort 3_800 mg (Fasting) · EG003: Dose escalation_Cohort 4_800 mg (Fed) · EG004: Dose expansion_PTCL_800 mg (Fasting) · EG005: Dose expansion_CTCL_800 mg (Fasting)

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypersensitivity
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    International normalized ratio increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Diplopia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Sepsis syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Skin Infection

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      19
      num Events
      5
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      20
      num Events
      13
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      10
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      19
      num Events
      5
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      20
      num Events
      15
    term
    Aspartate aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      19
      num Events
      2
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      20
      num Events
      8
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      20
      num Events
      7
    term
    Gamma-glutamyltransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Rash
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Muscle spasms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Pruritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      3
    term
    Blood thyroid stimulating hormone increased
Complete source fields
description
Summary of Related Treatment Emergent Adverse Events - All Patients
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    RP6530 administered 200 mg orally twice a day.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Dose escalation_Cohort 1_200 mg
  2. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    RP6530 administered 400 mg orally twice a day.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Dose escalation_Cohort 2_400 mg
  3. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Dose escalation_Cohort 3_800 mg (Fasting)
  4. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    RP6530 administered 800 mg orally twice a day under fed condition
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Dose escalation_Cohort 4_800 mg (Fed)
  5. deaths Num Affected
    3
    deaths Num At Risk
    19
    description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    EG004
    other Num Affected
    11
    other Num At Risk
    19
    serious Num Affected
    3
    serious Num At Risk
    19
    title
    Dose expansion_PTCL_800 mg (Fasting)
  6. deaths Num Affected
    1
    deaths Num At Risk
    20
    description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    EG005
    other Num Affected
    17
    other Num At Risk
    20
    serious Num Affected
    3
    serious Num At Risk
    20
    title
    Dose expansion_CTCL_800 mg (Fasting)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      19
      num Events
      5
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      20
      num Events
      13
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      10
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      19
      num Events
      5
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      20
      num Events
      15
    term
    Aspartate aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      19
      num Events
      2
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      20
      num Events
      8
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      20
      num Events
      7
    term
    Gamma-glutamyltransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Rash
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Muscle spasms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Pruritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      3
    term
    Blood thyroid stimulating hormone increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypersensitivity
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    International normalized ratio increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Diplopia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Sepsis syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Skin Infection
time Frame
24 months

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Preserved source evidence · Not medical advice