Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00556322 · ADVERSE EVENTS

Adverse events

A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2015-02-23

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
All adverse events (related and unrelated) occurring during the study and for up to 28 days after the last dose of study medication were reported.
Other-event reporting threshold
5%

All participants who received at least one dose of the trial medication and had at least one safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population (SAP).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Comparator

Participants received either Alimta 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or Taxotere 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, Taxotere was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.

31 / 213106 / 213Not reported / Not reported
Erlotinib

Participants received a single oral dose of erlotinib 150 mg/day until disease progression, unacceptable toxicity or death.

20 / 196125 / 196Not reported / Not reported

Group identifiers: EG000: Comparator · EG001: Erlotinib

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      196
    term
    Pulmonary embolism
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      196
    term
    Haemoptysis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Chronic obstructive pulmonary disease
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      196
    term
    Pulmonary effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      196
    term
    Pneumothorax
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Pulmonary haemorrhage
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      196
    term
    Back pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Abdominal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Enterocolitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Gastric perforation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Oesophagitis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      196
    term
    Rash
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Alopecia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      196
    term
    Dermatitis acneiform
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      196
    term
    Acne
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      196
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      196
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      196
    term
    Asthenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      196
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      196
    term
    Pyrexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      196
    term
    Chest pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      196
    term
    Oedema peripheral
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      196
    term
    Dyspnoea
Complete source fields
description
All participants who received at least one dose of the trial medication and had at least one safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population (SAP).
event Groups
  1. description
    Participants received either Alimta 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or Taxotere 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, Taxotere was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
    id
    EG000
    other Num Affected
    106
    other Num At Risk
    213
    serious Num Affected
    31
    serious Num At Risk
    213
    title
    Comparator
  2. description
    Participants received a single oral dose of erlotinib 150 mg/day until disease progression, unacceptable toxicity or death.
    id
    EG001
    other Num Affected
    125
    other Num At Risk
    196
    serious Num Affected
    20
    serious Num At Risk
    196
    title
    Erlotinib
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      196
    term
    Rash
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Alopecia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      196
    term
    Dermatitis acneiform
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      196
    term
    Acne
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      196
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      196
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      196
    term
    Asthenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      196
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      196
    term
    Pyrexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      196
    term
    Chest pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      196
    term
    Oedema peripheral
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      196
    term
    Dyspnoea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      196
    term
    Pulmonary embolism
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      196
    term
    Haemoptysis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Chronic obstructive pulmonary disease
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      196
    term
    Pulmonary effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      196
    term
    Pneumothorax
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Pulmonary haemorrhage
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      196
    term
    Back pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Abdominal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Enterocolitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Gastric perforation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      213
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      196
    term
    Oesophagitis
time Frame
All adverse events (related and unrelated) occurring during the study and for up to 28 days after the last dose of study medication were reported.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice