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NCT05091567 · ADVERSE EVENTS

Adverse events

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer · Source last updated 2026-09-09

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
Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
Other-event reporting threshold
5%

All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Atezolizumab + Carboplatin + Etoposide

Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide, in accordance with local standard of care, on Days 1, 2, and 3 of each cycle for up to 4 cycles.

181 / 653526 / 65354 / 660
Atezolizumab

Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.

41 / 240127 / 240135 / 241
Atezolizumab+ Lurbinectedin

Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.

75 / 242213 / 242113 / 242

Group identifiers: EG000: Atezolizumab + Carboplatin + Etoposide · EG001: Atezolizumab · EG002: Atezolizumab+ Lurbinectedin

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
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      653
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Hip fracture
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Lumbar vertebral fracture
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Cervical vertebral fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      242
      num Events
      1
    term
    Ankle fracture
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      653
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Infusion related reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Subdural haematoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Femur fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      242
      num Events
      1
    term
    Fall
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Road traffic accident
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Epidural haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      242
      num Events
      1
    term
    Panniculitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Adrenal insufficiency

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      653
      num Events
      110
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      242
      num Events
      1
    term
    Alopecia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      653
      num Events
      34
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      240
      num Events
      20
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      242
      num Events
      20
    term
    Pruritus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      653
      num Events
      15
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      240
      num Events
      22
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      242
      num Events
      18
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      653
      num Events
      81
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      240
      num Events
      19
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      242
      num Events
      47
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      653
      num Events
      88
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      240
      num Events
      21
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      242
      num Events
      59
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      653
      num Events
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      240
      num Events
      5
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      242
      num Events
      18
    term
    Hypomagnesaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      653
      num Events
      42
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      240
      num Events
      14
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      242
      num Events
      19
    term
    Hyponatraemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      653
      num Events
      69
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      240
      num Events
      18
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      242
      num Events
      51
    term
    Decreased appetite
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      653
      num Events
      46
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      240
      num Events
      15
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      242
      num Events
      21
    term
    Dyspnoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      653
      num Events
      30
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      240
      num Events
      16
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      242
      num Events
      23
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      653
      num Events
      84
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      240
      num Events
      4
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      242
      num Events
      53
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      268
      num At Risk
      653
      num Events
      319
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      240
      num Events
      16
    3. group Id
      EG002
      num Affected
      75
      num At Risk
      242
      num Events
      116
    term
    Anaemia
Complete source fields
description
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
event Groups
  1. deaths Num Affected
    54
    deaths Num At Risk
    660
    description
    Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide, in accordance with local standard of care, on Days 1, 2, and 3 of each cycle for up to 4 cycles.
    id
    EG000
    other Num Affected
    526
    other Num At Risk
    653
    serious Num Affected
    181
    serious Num At Risk
    653
    title
    Atezolizumab + Carboplatin + Etoposide
  2. deaths Num Affected
    135
    deaths Num At Risk
    241
    description
    Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
    id
    EG001
    other Num Affected
    127
    other Num At Risk
    240
    serious Num Affected
    41
    serious Num At Risk
    240
    title
    Atezolizumab
  3. deaths Num Affected
    113
    deaths Num At Risk
    242
    description
    Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
    id
    EG002
    other Num Affected
    213
    other Num At Risk
    242
    serious Num Affected
    75
    serious Num At Risk
    242
    title
    Atezolizumab+ Lurbinectedin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      653
      num Events
      110
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      242
      num Events
      1
    term
    Alopecia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      653
      num Events
      34
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      240
      num Events
      20
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      242
      num Events
      20
    term
    Pruritus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      653
      num Events
      15
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      240
      num Events
      22
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      242
      num Events
      18
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      653
      num Events
      81
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      240
      num Events
      19
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      242
      num Events
      47
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      653
      num Events
      88
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      240
      num Events
      21
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      242
      num Events
      59
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      653
      num Events
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      240
      num Events
      5
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      242
      num Events
      18
    term
    Hypomagnesaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      653
      num Events
      42
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      240
      num Events
      14
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      242
      num Events
      19
    term
    Hyponatraemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      653
      num Events
      69
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      240
      num Events
      18
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      242
      num Events
      51
    term
    Decreased appetite
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      653
      num Events
      46
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      240
      num Events
      15
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      242
      num Events
      21
    term
    Dyspnoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      653
      num Events
      30
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      240
      num Events
      16
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      242
      num Events
      23
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      653
      num Events
      84
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      240
      num Events
      4
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      242
      num Events
      53
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      268
      num At Risk
      653
      num Events
      319
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      240
      num Events
      16
    3. group Id
      EG002
      num Affected
      75
      num At Risk
      242
      num Events
      116
    term
    Anaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      653
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Hip fracture
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Lumbar vertebral fracture
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Cervical vertebral fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      242
      num Events
      1
    term
    Ankle fracture
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      653
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Infusion related reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Subdural haematoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Femur fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      242
      num Events
      1
    term
    Fall
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Road traffic accident
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      653
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Epidural haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      242
      num Events
      1
    term
    Panniculitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      653
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      242
      num Events
      0
    term
    Adrenal insufficiency
time Frame
Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.

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Preserved source evidence · Not medical advice