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NCT02601209 · ADVERSE EVENTS

Adverse events

Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma · Source last updated 2022-08-23

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
Up to 2 years
Other-event reporting threshold
0%

Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I - Dose Level 0

Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.

1 / 33 / 32 / 3
Phase I - Dose Level 1

Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.

0 / 33 / 31 / 3
Phase I - Dose Level 2

Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.

0 / 33 / 33 / 3
Phase II - Analysis Group 1 MLN0128

Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.

5 / 1212 / 129 / 12
Phase II - Analysis Group 1 Pazopanib

Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.

6 / 1212 / 125 / 12
Phase II - Analysis Group 2 MLN0128

Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.

20 / 5554 / 5527 / 55
Phase II - Analysis Group 2 Pazopanib

Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.

24 / 5655 / 5624 / 56

Group identifiers: EG000: Phase I - Dose Level 0 · EG001: Phase I - Dose Level 1 · EG002: Phase I - Dose Level 2 · EG003: Phase II - Analysis Group 1 MLN0128 · EG004: Phase II - Analysis Group 1 Pazopanib · EG005: Phase II - Analysis Group 2 MLN0128 · EG006: Phase II - Analysis Group 2 Pazopanib

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 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      56
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      2
    term
    Retinal tear
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      56
      num Events
      3
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      2
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Fecal incontinence
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Gastrointestinal disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Jejunal perforation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      55
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Mucositis oral

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 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      12
      num Events
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      55
      num Events
      21
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      56
      num Events
      27
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      55
      num Events
      6
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      56
      num Events
      6
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      2
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      1
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      56
      num Events
      4
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Ear and labyrinth disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      55
      num Events
      15
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Endocrine disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      5
    term
    Hyperthyroidism
Complete source fields
description
Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase I - Dose Level 0
  2. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Phase I - Dose Level 1
  3. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Phase I - Dose Level 2
  4. deaths Num Affected
    9
    deaths Num At Risk
    12
    description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
    id
    EG003
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    5
    serious Num At Risk
    12
    title
    Phase II - Analysis Group 1 MLN0128
  5. deaths Num Affected
    5
    deaths Num At Risk
    12
    description
    Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.
    id
    EG004
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    6
    serious Num At Risk
    12
    title
    Phase II - Analysis Group 1 Pazopanib
  6. deaths Num Affected
    27
    deaths Num At Risk
    55
    description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
    id
    EG005
    other Num Affected
    54
    other Num At Risk
    55
    serious Num Affected
    20
    serious Num At Risk
    55
    title
    Phase II - Analysis Group 2 MLN0128
  7. deaths Num Affected
    24
    deaths Num At Risk
    56
    description
    Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
    id
    EG006
    other Num Affected
    55
    other Num At Risk
    56
    serious Num Affected
    24
    serious Num At Risk
    56
    title
    Phase II - Analysis Group 2 Pazopanib
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      12
      num Events
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      55
      num Events
      21
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      56
      num Events
      27
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      55
      num Events
      6
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      56
      num Events
      6
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      2
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      1
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      56
      num Events
      4
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Ear and labyrinth disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      55
      num Events
      15
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Endocrine disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      5
    term
    Hyperthyroidism
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      56
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      2
    term
    Retinal tear
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      56
      num Events
      3
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      2
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Fecal incontinence
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      55
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Gastrointestinal disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      55
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Jejunal perforation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      55
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Mucositis oral
time Frame
Up to 2 years

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Preserved source evidence · Not medical advice