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NCT00755040 · ADVERSE EVENTS

Adverse events

Cyclosporine Eye Drops in Preventing Graft-Versus-Host Disease of the Eye in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer or Bone Marrow Failure Disorder · Source last updated 2017-03-07

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I

Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. cyclosporine ophthalmic emulsion: Given as eye drops

3 / 8349 / 83Not reported / Not reported
Arm II

Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. placebo: Given as eye drops

7 / 8118 / 81Not reported / Not reported

Group identifiers: EG000: Arm I · EG001: Arm II

Serious adverse events

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

  1. notes
    Relapse of underlying disease
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      81
      num Events
      4
    term
    Blood/Bone Marrow
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      81
      num Events
      1
    term
    Multi-organ failure
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      81
      num Events
      2
    term
    Blood/Bone Marrow Other

Other reported adverse events

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

  1. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      83
      num Events
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      81
      num Events
      18
    term
    Burning
  2. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      83
      num Events
      13
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      81
      num Events
      22
    term
    Red eye
  3. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      83
      num Events
      13
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      81
      num Events
      8
    term
    Discharge
  4. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      83
      num Events
      20
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      81
      num Events
      21
    term
    Excessive tearing
  5. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      81
      num Events
      6
    term
    Eye pain
  6. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
      num Events
      5
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      81
      num Events
      9
    term
    Foreign Body Sensation
  7. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      83
      num Events
      20
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      81
      num Events
      13
    term
    Itching
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
      num Events
      22
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      81
      num Events
      9
    term
    Stinging
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      83
      num Events
      14
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      81
      num Events
      23
    term
    Visual disturbance
Complete source fields
event Groups
  1. description
    Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. cyclosporine ophthalmic emulsion: Given as eye drops
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    83
    serious Num Affected
    3
    serious Num At Risk
    83
    title
    Arm I
  2. description
    Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. placebo: Given as eye drops
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    81
    serious Num Affected
    7
    serious Num At Risk
    81
    title
    Arm II
frequency Threshold
5
other Events
  1. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      83
      num Events
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      81
      num Events
      18
    term
    Burning
  2. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      83
      num Events
      13
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      81
      num Events
      22
    term
    Red eye
  3. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      83
      num Events
      13
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      81
      num Events
      8
    term
    Discharge
  4. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      83
      num Events
      20
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      81
      num Events
      21
    term
    Excessive tearing
  5. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      81
      num Events
      6
    term
    Eye pain
  6. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
      num Events
      5
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      81
      num Events
      9
    term
    Foreign Body Sensation
  7. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      83
      num Events
      20
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      81
      num Events
      13
    term
    Itching
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
      num Events
      22
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      81
      num Events
      9
    term
    Stinging
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      83
      num Events
      14
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      81
      num Events
      23
    term
    Visual disturbance
serious Events
  1. notes
    Relapse of underlying disease
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      81
      num Events
      4
    term
    Blood/Bone Marrow
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      81
      num Events
      1
    term
    Multi-organ failure
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      81
      num Events
      2
    term
    Blood/Bone Marrow Other

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Preserved source evidence · Not medical advice