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NCT03521154 · ADVERSE EVENTS

Adverse events

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA) · Source last updated 2026-08-04

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 time of signature of informed consent throughout the treatment period (maximum actual duration of 62.4 and 56.2 months for Osimertinib and Placebo respectively) up to and including 28 day follow up following last dose of study drug.
Other-event reporting threshold
5%

The initial dose of osimertinib/placebo 80 mg QD could be reduced to 40 mg QD to allow for management of study treatment-related toxicities. Once the dose of osimertinib/placebo was reduced to 40 mg QD, the patient was to remain on the reduced dose until termination from study treatment

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

80mg once daily tablet

55 / 143129 / 14328 / 143
Placebo

Matching Placebo

11 / 7354 / 7315 / 73

Group identifiers: EG000: Osimertinib · EG001: Placebo

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Large intestine polyp
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      143
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Oesophageal stenosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      143
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Malaise
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Hepatic failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Bacterial pyelonephritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Biliary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Bronchitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Covid-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Chronic hepatitis b
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Dengue fever

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      143
      num Events
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
      num Events
      2
    term
    Stomatitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      143
      num Events
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      73
      num Events
      3
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      143
      num Events
      28
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      73
      num Events
      6
    term
    Covid-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      143
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
      num Events
      2
    term
    Herpes zoster
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      143
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Nasopharyngitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      143
      num Events
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Paronychia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      143
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      73
      num Events
      5
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      143
      num Events
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      143
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
      num Events
      2
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      143
      num Events
      55
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      73
      num Events
      27
    term
    Radiation pneumonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      143
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
      num Events
      2
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      143
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Aspartate aminotransferase increased
Complete source fields
description
The initial dose of osimertinib/placebo 80 mg QD could be reduced to 40 mg QD to allow for management of study treatment-related toxicities. Once the dose of osimertinib/placebo was reduced to 40 mg QD, the patient was to remain on the reduced dose until termination from study treatment
event Groups
  1. deaths Num Affected
    28
    deaths Num At Risk
    143
    description
    80mg once daily tablet
    id
    EG000
    other Num Affected
    129
    other Num At Risk
    143
    serious Num Affected
    55
    serious Num At Risk
    143
    title
    Osimertinib
  2. deaths Num Affected
    15
    deaths Num At Risk
    73
    description
    Matching Placebo
    id
    EG001
    other Num Affected
    54
    other Num At Risk
    73
    serious Num Affected
    11
    serious Num At Risk
    73
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      143
      num Events
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
      num Events
      2
    term
    Stomatitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      143
      num Events
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      73
      num Events
      3
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      143
      num Events
      28
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      73
      num Events
      6
    term
    Covid-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      143
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
      num Events
      2
    term
    Herpes zoster
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      143
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Nasopharyngitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      143
      num Events
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Paronychia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      143
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      73
      num Events
      5
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      143
      num Events
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      143
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
      num Events
      2
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      143
      num Events
      55
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      73
      num Events
      27
    term
    Radiation pneumonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      143
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
      num Events
      2
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      143
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Aspartate aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Large intestine polyp
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      143
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Oesophageal stenosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      143
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
      num Events
      1
    term
    Malaise
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Hepatic failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Bacterial pyelonephritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Biliary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Bronchitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Covid-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Chronic hepatitis b
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
      num Events
      0
    term
    Dengue fever
time Frame
From the time of signature of informed consent throughout the treatment period (maximum actual duration of 62.4 and 56.2 months for Osimertinib and Placebo respectively) up to and including 28 day follow up following last dose of study drug.

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