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NCT00470366 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors · Source last updated 2017-11-28

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
Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Paclitaxel, Ifosfamide, and Cisplatin

-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel

34 / 6060 / 605 / 60

Group identifiers: EG000: Paclitaxel, Ifosfamide, and 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
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    term
    Allergy/Immunology, other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Atrial tachycardia/Paroxysmal Atrial Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    term
    Cardiac General, other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Chyle or lymph leakage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Confusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Cough
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    term
    Creatinine
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Cystitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Diarrhea

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
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      60
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      60
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      60
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      60
    term
    Leukocytes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      60
    term
    Neutrophils/granulocytes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      60
    term
    Platelets
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      60
    term
    ALT
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      60
    term
    Neuropathy: sensory
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      60
    term
    Hyponatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      60
    term
    Hyperglycemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      60
    term
    AST
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      60
    term
    Hypoalbuminemia
Complete source fields
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    60
    description
    -Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel
    id
    EG000
    other Num Affected
    60
    other Num At Risk
    60
    serious Num Affected
    34
    serious Num At Risk
    60
    title
    Paclitaxel, Ifosfamide, and Cisplatin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      60
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      60
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      60
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      60
    term
    Leukocytes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      60
    term
    Neutrophils/granulocytes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      60
    term
    Platelets
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      60
    term
    ALT
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      60
    term
    Neuropathy: sensory
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      60
    term
    Hyponatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      60
    term
    Hyperglycemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      60
    term
    AST
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      60
    term
    Hypoalbuminemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    term
    Allergy/Immunology, other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Atrial tachycardia/Paroxysmal Atrial Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    term
    Cardiac General, other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Chyle or lymph leakage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Confusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Cough
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    term
    Creatinine
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Cystitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    term
    Diarrhea
time Frame
Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.

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