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NCT00851877 · ADVERSE EVENTS

Adverse events

Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer · Source last updated 2020-08-21

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
Through study completion, and average of 2 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy

Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy

3 / 3432 / 341 / 34

Group identifiers: EG000: Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Nab-Paclitaxel toxicity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    grade 4 larynx edema

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
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      34
      num Events
      7
    term
    hypothyroidism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      34
      num Events
      15
    term
    larynx edema
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
      num Events
      10
    term
    xerostomia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
      num Events
      4
    term
    fibrosis
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    34
    description
    Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    34
    serious Num Affected
    3
    serious Num At Risk
    34
    title
    Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      34
      num Events
      7
    term
    hypothyroidism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      34
      num Events
      15
    term
    larynx edema
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
      num Events
      10
    term
    xerostomia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
      num Events
      4
    term
    fibrosis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Nab-Paclitaxel toxicity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    grade 4 larynx edema
time Frame
Through study completion, and average of 2 years.

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

Preserved source evidence · Not medical advice