Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00512096 · ADVERSE EVENTS

Adverse events

Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis · Source last updated 2012-08-01

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
Nine years and 6 months
Other-event reporting threshold
2%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cisplatin + Ifosfamide + Paclitaxel

Cisplatin 25 mg/m\^2 IV Days 1-3; Ifosfamide 1200 mg/m\^2 IV Days 1-3; Paclitaxel 175 mg/m\^2 IV Day 1

3 / 3013 / 30Not reported / Not reported

Group identifiers: EG000: Cisplatin + Ifosfamide + Paclitaxel

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
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    myocarcial ischemia

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
    notes
    grade 3 only, no grade 4 events
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 4 only, no grade 3 events
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 events, no grade 4
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
      num Events
      5
    term
    infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    no grade 4 events
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    deep vein thrombosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3, no grade 4 events
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    central venous catheter related thrombosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3, no grade 4 events
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 event, no grade 4 events
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    hyperglycemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 event, no grade 4 events
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    neuropathy motor
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 event, no grade 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    thrombocytopenia
Complete source fields
event Groups
  1. description
    Cisplatin 25 mg/m\^2 IV Days 1-3; Ifosfamide 1200 mg/m\^2 IV Days 1-3; Paclitaxel 175 mg/m\^2 IV Day 1
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    30
    serious Num Affected
    3
    serious Num At Risk
    30
    title
    Cisplatin + Ifosfamide + Paclitaxel
frequency Threshold
2
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 only, no grade 4 events
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 4 only, no grade 3 events
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 events, no grade 4
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
      num Events
      5
    term
    infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    no grade 4 events
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    deep vein thrombosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3, no grade 4 events
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    central venous catheter related thrombosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3, no grade 4 events
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 event, no grade 4 events
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    hyperglycemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 event, no grade 4 events
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    neuropathy motor
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grade 3 event, no grade 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    thrombocytopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    myocarcial ischemia
time Frame
Nine years and 6 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice