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NCT00716976 · ADVERSE EVENTS

Adverse events

Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy · Source last updated 2023-11-09

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
0%

Serious Adverse Events were reported on this study via the NCI AERS reporting system. Per protocol, no expedited reports were submitted for patients on Observation only arm of the study. Thus, no patients enrolled on the Observation arm of the trial were at risk for having a Serious Adverse Event reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
STS Arm (Sodium Thiosulfate Treatment)

Not reported

21 / 5951 / 59Not reported / Not reported
Observation Arm

Not reported

0 / 057 / 64Not reported / Not reported

Group identifiers: EG000: STS Arm (Sodium Thiosulfate Treatment) · EG001: Observation Arm

Serious adverse events

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

  1. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Abdominal infection
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Abdominal pain
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Acidosis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Alanine aminotransferase increased
  5. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anaphylaxis
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anemia
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anorexia
  8. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anxiety
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Aspartate aminotransferase increased
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Cardiac arrest
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Colitis
  12. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Conjunctivitis

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
    term
    Abdominal infection
  2. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
    term
    Acidosis
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      64
    term
    Alanine aminotransferase increased
  4. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      64
    term
    Allergic reaction
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      64
    term
    Anemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
    term
    Anorexia
  7. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
    term
    Anxiety
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      64
    term
    Aspartate aminotransferase increased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
    term
    Blood bilirubin increased
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
    term
    Bone infection
  11. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
    term
    Bone pain
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      64
    term
    Catheter related infection
Complete source fields
description
Serious Adverse Events were reported on this study via the NCI AERS reporting system. Per protocol, no expedited reports were submitted for patients on Observation only arm of the study. Thus, no patients enrolled on the Observation arm of the trial were at risk for having a Serious Adverse Event reported.
event Groups
  1. id
    EG000
    other Num Affected
    51
    other Num At Risk
    59
    serious Num Affected
    21
    serious Num At Risk
    59
    title
    STS Arm (Sodium Thiosulfate Treatment)
  2. id
    EG001
    other Num Affected
    57
    other Num At Risk
    64
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Observation Arm
frequency Threshold
0
other Events
  1. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
    term
    Abdominal infection
  2. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
    term
    Acidosis
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      64
    term
    Alanine aminotransferase increased
  4. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      64
    term
    Allergic reaction
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      64
    term
    Anemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
    term
    Anorexia
  7. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
    term
    Anxiety
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      64
    term
    Aspartate aminotransferase increased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
    term
    Blood bilirubin increased
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
    term
    Bone infection
  11. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
    term
    Bone pain
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      64
    term
    Catheter related infection
serious Events
  1. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Abdominal infection
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Abdominal pain
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Acidosis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Alanine aminotransferase increased
  5. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anaphylaxis
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anemia
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anorexia
  8. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anxiety
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Aspartate aminotransferase increased
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Cardiac arrest
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Colitis
  12. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Conjunctivitis

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Preserved source evidence · Not medical advice