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NCT01611662 · ADVERSE EVENTS

Adverse events

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer · Source last updated 2019-07-29

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)

Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. gemcitabine hydrochloride: Given IV cisplatin: Given IV therapeutic conventional surgery: Undergo radical cystectomy laboratory biomarker analysis: Correlative studies

16 / 3131 / 31Not reported / Not reported

Group identifiers: EG000: Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    term
    Chest pain
  2. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    term
    Deep Vein Thrombosis
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Acute Kidney Injury
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Constipation
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Acute Renal Insufficiency
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Coronary Artey Disease
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    dyspnea
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Myocardial Infarction
  9. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    hypotension
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Pulmonary embolism
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    pneumonia
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    infected lymphocele

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      31
    term
    Anemia
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Atrial Fibrilation
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    term
    Chest pain
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Myocardial Infarction
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Sinus Brachycardia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Sinus Trachycardia
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Cardiac Faliure
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Acute coronary syndrome
  9. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Hearing Impaired
  10. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Blurred Vision
  11. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      31
    term
    Tinnitus
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      31
    term
    Constipation
Complete source fields
event Groups
  1. description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. gemcitabine hydrochloride: Given IV cisplatin: Given IV therapeutic conventional surgery: Undergo radical cystectomy laboratory biomarker analysis: Correlative studies
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    16
    serious Num At Risk
    31
    title
    Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      31
    term
    Anemia
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Atrial Fibrilation
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    term
    Chest pain
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Myocardial Infarction
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Sinus Brachycardia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Sinus Trachycardia
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Cardiac Faliure
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Acute coronary syndrome
  9. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Hearing Impaired
  10. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Blurred Vision
  11. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      31
    term
    Tinnitus
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      31
    term
    Constipation
serious Events
  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    term
    Chest pain
  2. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    term
    Deep Vein Thrombosis
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Acute Kidney Injury
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Constipation
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Acute Renal Insufficiency
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Coronary Artey Disease
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    dyspnea
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Myocardial Infarction
  9. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    hypotension
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Pulmonary embolism
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    pneumonia
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    infected lymphocele

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Preserved source evidence · Not medical advice