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NCT00002558 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors · Source last updated 2016-05-23

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

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

Collection time frame
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group A: <= 6 Cycles of Cisplatin

Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin

7 / 9292 / 92Not reported / Not reported
Group: B > 6 Cycles of Cisplatin

Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin

2 / 1615 / 16Not reported / Not reported

Group identifiers: EG000: Group A: <= 6 Cycles of Cisplatin · EG001: Group: B > 6 Cycles of Cisplatin

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
    Nervous system disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    CNS hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Neurology, other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      92
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Pulmonary, other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Syncope
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Catheter related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Infection

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
    Gastrointestinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Abdominal pain/cramping
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      92
      num Events
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Alkaline phosphatase
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      92
      num Events
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
      num Events
      4
    term
    Bilirubin
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      92
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Catheter-related infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Creatinine
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      92
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Dermatology, skin other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Dizziness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      92
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Dyspnea
Complete source fields
event Groups
  1. description
    Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin
    id
    EG000
    other Num Affected
    92
    other Num At Risk
    92
    serious Num Affected
    7
    serious Num At Risk
    92
    title
    Group A: <= 6 Cycles of Cisplatin
  2. description
    Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    16
    serious Num Affected
    2
    serious Num At Risk
    16
    title
    Group: B > 6 Cycles of Cisplatin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Abdominal pain/cramping
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      92
      num Events
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Alkaline phosphatase
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      92
      num Events
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
      num Events
      4
    term
    Bilirubin
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      92
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Catheter-related infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Creatinine
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      92
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Dermatology, skin other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Dizziness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      92
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Dyspnea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    CNS hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Neurology, other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      92
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Pulmonary, other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Syncope
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Catheter related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Infection

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