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NCT02048371 · ADVERSE EVENTS

Adverse events

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes · Source last updated 2023-11-07

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

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

Collection time frame
Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Other-event reporting threshold
5%

Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A: Liposarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

28 / 3926 / 3925 / 39
Cohort A: Liposarcoma, Placebo

21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off

7 / 98 / 97 / 9
Cohort B: Osteosarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

24 / 3326 / 3326 / 33
Cohort B: Osteosarcoma, Placebo

21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off

7 / 96 / 98 / 9
Cohort C: Ewing Sarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

21 / 3022 / 3017 / 30
Cohort D: Rhabdomyosarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

4 / 62 / 64 / 6
Cohort D: Pediatric

Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

2 / 41 / 42 / 4
Cohort E: Mesenchymal Chondrosarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

0 / 10 / 10 / 1

Group identifiers: EG000: Cohort A: Liposarcoma · EG001: Cohort A: Liposarcoma, Placebo · EG002: Cohort B: Osteosarcoma · EG003: Cohort B: Osteosarcoma, Placebo · EG004: Cohort C: Ewing Sarcoma · EG005: Cohort D: Rhabdomyosarcoma · EG006: Cohort D: Pediatric · EG007: Cohort E: Mesenchymal Chondrosarcoma

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Low Phosphate
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Elevated AST/SGOT
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Amylase Elevation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Decreased WBC
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hyperfibrinolysis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Lipase Elevation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Alkaline Phosphatase Elevated
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Loss of Vision, Left Eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Vision Loss, Right Eye
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Abdominal Pain

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      33
      num Events
      19
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Hypertension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Alkaline Phosphatase Elevated
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Blurred vision
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Vision Loss, Right Eye
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      30
      num Events
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      33
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      30
      num Events
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      33
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Mucositis oral
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Fever
Complete source fields
description
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
event Groups
  1. deaths Num Affected
    25
    deaths Num At Risk
    39
    description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    39
    serious Num Affected
    28
    serious Num At Risk
    39
    title
    Cohort A: Liposarcoma
  2. deaths Num Affected
    7
    deaths Num At Risk
    9
    description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    7
    serious Num At Risk
    9
    title
    Cohort A: Liposarcoma, Placebo
  3. deaths Num Affected
    26
    deaths Num At Risk
    33
    description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    EG002
    other Num Affected
    26
    other Num At Risk
    33
    serious Num Affected
    24
    serious Num At Risk
    33
    title
    Cohort B: Osteosarcoma
  4. deaths Num Affected
    8
    deaths Num At Risk
    9
    description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    9
    serious Num Affected
    7
    serious Num At Risk
    9
    title
    Cohort B: Osteosarcoma, Placebo
  5. deaths Num Affected
    17
    deaths Num At Risk
    30
    description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    EG004
    other Num Affected
    22
    other Num At Risk
    30
    serious Num Affected
    21
    serious Num At Risk
    30
    title
    Cohort C: Ewing Sarcoma
  6. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Cohort D: Rhabdomyosarcoma
  7. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Cohort D: Pediatric
  8. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    EG007
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Cohort E: Mesenchymal Chondrosarcoma
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      33
      num Events
      19
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Hypertension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Alkaline Phosphatase Elevated
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Blurred vision
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Vision Loss, Right Eye
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      30
      num Events
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      33
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      30
      num Events
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      33
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Mucositis oral
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Fever
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Low Phosphate
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Elevated AST/SGOT
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Amylase Elevation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Decreased WBC
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hyperfibrinolysis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Lipase Elevation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Alkaline Phosphatase Elevated
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Loss of Vision, Left Eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Vision Loss, Right Eye
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTECA Version 4.03
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      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
      1
      num Events
      0
    term
    Abdominal Pain
time Frame
Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).

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Preserved source evidence · Not medical advice