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NCT03052608 · ADVERSE EVENTS

Adverse events

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC · Source last updated 2025-11-25

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
From the first dose of study treatment through end of study follow-up (infinite lag) or start of new anti-cancer therapy, whichever occurred first (assessed up to 33 months).
Other-event reporting threshold
5%

The analysis of adverse events included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment assigned at randomization. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different adverse events within the higher level category.

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

Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

51 / 149148 / 14923 / 149
Crizotinib

Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

39 / 142140 / 14228 / 142

Group identifiers: EG000: Lorlatinib · EG001: Crizotinib

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 v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Cardiac disorder
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Cardiac failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Cardiac failure acute
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Cardiac tamponade
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Left ventricular dysfunction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Pericardial effusion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Sinus node dysfunction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Blindness cortical
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Retinal detachment
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Diarrhoea

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 v23.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      142
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      142
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      142
    term
    Bradycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      142
    term
    Sinus bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      142
    term
    Photopsia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      142
    term
    Vision blurred
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      142
    term
    Visual impairment
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      142
    term
    Abdominal distension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      142
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      142
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      142
    term
    Diarrhoea
Complete source fields
description
The analysis of adverse events included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment assigned at randomization. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different adverse events within the higher level category.
event Groups
  1. deaths Num Affected
    23
    deaths Num At Risk
    149
    description
    Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    EG000
    other Num Affected
    148
    other Num At Risk
    149
    serious Num Affected
    51
    serious Num At Risk
    149
    title
    Lorlatinib
  2. deaths Num Affected
    28
    deaths Num At Risk
    142
    description
    Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    EG001
    other Num Affected
    140
    other Num At Risk
    142
    serious Num Affected
    39
    serious Num At Risk
    142
    title
    Crizotinib
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      142
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      142
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      142
    term
    Bradycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      142
    term
    Sinus bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      142
    term
    Photopsia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      142
    term
    Vision blurred
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      142
    term
    Visual impairment
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      142
    term
    Abdominal distension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      142
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      142
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      142
    term
    Diarrhoea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Cardiac disorder
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Cardiac failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Cardiac failure acute
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Cardiac tamponade
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Left ventricular dysfunction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Pericardial effusion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Sinus node dysfunction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Blindness cortical
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Retinal detachment
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
    term
    Diarrhoea
time Frame
From the first dose of study treatment through end of study follow-up (infinite lag) or start of new anti-cancer therapy, whichever occurred first (assessed up to 33 months).

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