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NCT01154140 · ADVERSE EVENTS

Adverse events

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

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
Baseline up to follow up period (up to 72 months)
Other-event reporting threshold
5%

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

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

Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

71 / 171169 / 171Not reported / Not reported
Chemotherapy

Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.

49 / 169164 / 169Not reported / Not reported

Group identifiers: EG000: Crizotinib · EG001: Chemotherapy

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Lymphadenopathy mediastinal
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Atrial fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Atrioventricular block
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Pericardial effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Pericarditis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      169
    term
    Syncope
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Dysphagia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Haemorrhoids
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Intestinal obstruction

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      169
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      169
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      169
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      169
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      169
    term
    Photopsia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      169
    term
    Vision blurred
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      169
    term
    Visual impairment
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Vitreous floaters
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      169
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      169
    term
    Abdominal pain upper
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      169
    term
    Constipation
Complete source fields
description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
event Groups
  1. description
    Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
    id
    EG000
    other Num Affected
    169
    other Num At Risk
    171
    serious Num Affected
    71
    serious Num At Risk
    171
    title
    Crizotinib
  2. description
    Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
    id
    EG001
    other Num Affected
    164
    other Num At Risk
    169
    serious Num Affected
    49
    serious Num At Risk
    169
    title
    Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      169
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      169
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      169
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      169
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      169
    term
    Photopsia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      169
    term
    Vision blurred
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      169
    term
    Visual impairment
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Vitreous floaters
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      169
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      169
    term
    Abdominal pain upper
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      169
    term
    Constipation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Lymphadenopathy mediastinal
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Atrial fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Atrioventricular block
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Pericardial effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Pericarditis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      169
    term
    Syncope
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    term
    Dysphagia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Haemorrhoids
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      171
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    term
    Intestinal obstruction
time Frame
Baseline up to follow up period (up to 72 months)

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