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NCT01096368 · ADVERSE EVENTS

Adverse events

Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma · Source last updated 2026-04-30

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
Enrollment up to 10 years after enrollment.
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I: Observation

Patients with classic histology (WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

0 / 370 / 370 / 37
Arm II: Randomized to Radiation With Maintenance Chemotherapy

Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.

5 / 16422 / 16420 / 164
Arm III: Randomized to Radiation Only

Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation.

0 / 16110 / 16127 / 161
Arm IV: Nonrandomly Assigned to Arm II Treatment

Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.

1 / 6315 / 6322 / 63
Not Ependymoma or Withdrew Before Radiation

Patients with tumor other than ependymoma or withdrew before protocol-specified radiotherapy administered

0 / 244 / 244 / 24

Group identifiers: EG000: Arm I: Observation · EG001: Arm II: Randomized to Radiation With Maintenance Chemotherapy · EG002: Arm III: Randomized to Radiation Only · EG003: Arm IV: Nonrandomly Assigned to Arm II Treatment · EG004: Not Ependymoma or Withdrew Before Radiation

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hypernatremia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Treatment related secondary malignancy

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Ear and labyrinth disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hearing impaired
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Meningitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Lymphocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    White blood cell decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hyperglycemia
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    37
    description
    Patients with classic histology (WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    37
    serious Num Affected
    0
    serious Num At Risk
    37
    title
    Arm I: Observation
  2. deaths Num Affected
    20
    deaths Num At Risk
    164
    description
    Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    164
    serious Num Affected
    5
    serious Num At Risk
    164
    title
    Arm II: Randomized to Radiation With Maintenance Chemotherapy
  3. deaths Num Affected
    27
    deaths Num At Risk
    161
    description
    Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    161
    serious Num Affected
    0
    serious Num At Risk
    161
    title
    Arm III: Randomized to Radiation Only
  4. deaths Num Affected
    22
    deaths Num At Risk
    63
    description
    Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.
    id
    EG003
    other Num Affected
    15
    other Num At Risk
    63
    serious Num Affected
    1
    serious Num At Risk
    63
    title
    Arm IV: Nonrandomly Assigned to Arm II Treatment
  5. deaths Num Affected
    4
    deaths Num At Risk
    24
    description
    Patients with tumor other than ependymoma or withdrew before protocol-specified radiotherapy administered
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    24
    serious Num Affected
    0
    serious Num At Risk
    24
    title
    Not Ependymoma or Withdrew Before Radiation
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Ear and labyrinth disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hearing impaired
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Meningitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Lymphocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    White blood cell decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hyperglycemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hypernatremia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      164
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      161
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Treatment related secondary malignancy
time Frame
Enrollment up to 10 years after enrollment.

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Preserved source evidence · Not medical advice