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NCT03088540 · ADVERSE EVENTS

Adverse events

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-06-25

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 signing of first informed consent up to 94 months.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cemiplimab

Participants received cemiplimab monotherapy

131 / 356287 / 356178 / 356
Extended Treatment: Cemiplimab + Chemotherapy

Participants originally assigned to cemiplimab received cemiplimab with chemotherapy after initial disease progression.

23 / 8570 / 8560 / 85
Chemotherapy

Participants received platinum-based doublet chemotherapy

103 / 343319 / 343116 / 343
Crossover: Chemotherapy to Cemiplimab

Participants received cemiplimab after initial disease progression on chemotherapy.

57 / 191141 / 191141 / 191

Group identifiers: EG000: Cemiplimab · EG001: Extended Treatment: Cemiplimab + Chemotherapy · EG002: Chemotherapy · EG003: Crossover: Chemotherapy to Cemiplimab

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
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      356
      num Events
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      343
      num Events
      24
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      191
      num Events
      9
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      356
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      343
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Septic shock
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      356
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      191
      num Events
      2
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      356
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      343
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      356
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      191
      num Events
      1
    term
    Lower respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      356
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      343
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      191
      num Events
      2
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      356
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      343
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Upper respiratory tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Abscess limb
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      191
      num Events
      1
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Biliary tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      343
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      191
      num Events
      1
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      343
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Cellulitis

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
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      356
      num Events
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      85
      num Events
      7
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      343
      num Events
      72
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      191
      num Events
      22
    term
    Decreased appetite
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      356
      num Events
      37
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      85
      num Events
      10
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      343
      num Events
      36
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      191
      num Events
      22
    term
    Hypoalbuminaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      356
      num Events
      34
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
      num Events
      8
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      343
      num Events
      19
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      191
      num Events
      14
    term
    Hyperglycaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      356
      num Events
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      85
      num Events
      3
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      343
      num Events
      23
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      191
      num Events
      20
    term
    Hyponatraemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      356
      num Events
      15
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
      num Events
      8
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      343
      num Events
      43
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      191
      num Events
      25
    term
    Hypomagnesaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      356
      num Events
      15
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
      num Events
      7
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      343
      num Events
      11
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      191
      num Events
      9
    term
    Hypocalcaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      356
      num Events
      52
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      85
      num Events
      9
    3. group Id
      EG002
      num Affected
      65
      num At Risk
      343
      num Events
      76
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      191
      num Events
      23
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      356
      num Events
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      85
      num Events
      2
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      343
      num Events
      16
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      191
      num Events
      5
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      356
      num Events
      25
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      85
      num Events
      13
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      343
      num Events
      39
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      191
      num Events
      14
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      356
      num Events
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      2
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      343
      num Events
      16
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      191
      num Events
      4
    term
    Non-cardiac chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      356
      num Events
      47
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      85
      num Events
      6
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      343
      num Events
      24
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      191
      num Events
      29
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      356
      num Events
      45
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
      num Events
      5
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      343
      num Events
      22
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      191
      num Events
      30
    term
    Aspartate aminotransferase increased
Complete source fields
event Groups
  1. deaths Num Affected
    178
    deaths Num At Risk
    356
    description
    Participants received cemiplimab monotherapy
    id
    EG000
    other Num Affected
    287
    other Num At Risk
    356
    serious Num Affected
    131
    serious Num At Risk
    356
    title
    Cemiplimab
  2. deaths Num Affected
    60
    deaths Num At Risk
    85
    description
    Participants originally assigned to cemiplimab received cemiplimab with chemotherapy after initial disease progression.
    id
    EG001
    other Num Affected
    70
    other Num At Risk
    85
    serious Num Affected
    23
    serious Num At Risk
    85
    title
    Extended Treatment: Cemiplimab + Chemotherapy
  3. deaths Num Affected
    116
    deaths Num At Risk
    343
    description
    Participants received platinum-based doublet chemotherapy
    id
    EG002
    other Num Affected
    319
    other Num At Risk
    343
    serious Num Affected
    103
    serious Num At Risk
    343
    title
    Chemotherapy
  4. deaths Num Affected
    141
    deaths Num At Risk
    191
    description
    Participants received cemiplimab after initial disease progression on chemotherapy.
    id
    EG003
    other Num Affected
    141
    other Num At Risk
    191
    serious Num Affected
    57
    serious Num At Risk
    191
    title
    Crossover: Chemotherapy to Cemiplimab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      356
      num Events
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      85
      num Events
      7
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      343
      num Events
      72
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      191
      num Events
      22
    term
    Decreased appetite
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      356
      num Events
      37
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      85
      num Events
      10
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      343
      num Events
      36
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      191
      num Events
      22
    term
    Hypoalbuminaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      356
      num Events
      34
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
      num Events
      8
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      343
      num Events
      19
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      191
      num Events
      14
    term
    Hyperglycaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      356
      num Events
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      85
      num Events
      3
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      343
      num Events
      23
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      191
      num Events
      20
    term
    Hyponatraemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      356
      num Events
      15
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
      num Events
      8
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      343
      num Events
      43
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      191
      num Events
      25
    term
    Hypomagnesaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      356
      num Events
      15
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
      num Events
      7
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      343
      num Events
      11
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      191
      num Events
      9
    term
    Hypocalcaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      356
      num Events
      52
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      85
      num Events
      9
    3. group Id
      EG002
      num Affected
      65
      num At Risk
      343
      num Events
      76
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      191
      num Events
      23
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      356
      num Events
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      85
      num Events
      2
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      343
      num Events
      16
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      191
      num Events
      5
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      356
      num Events
      25
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      85
      num Events
      13
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      343
      num Events
      39
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      191
      num Events
      14
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      356
      num Events
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      2
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      343
      num Events
      16
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      191
      num Events
      4
    term
    Non-cardiac chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      356
      num Events
      47
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      85
      num Events
      6
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      343
      num Events
      24
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      191
      num Events
      29
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      356
      num Events
      45
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
      num Events
      5
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      343
      num Events
      22
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      191
      num Events
      30
    term
    Aspartate aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      356
      num Events
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      343
      num Events
      24
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      191
      num Events
      9
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      356
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      343
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Septic shock
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      356
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      191
      num Events
      2
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      356
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      343
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      356
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      191
      num Events
      1
    term
    Lower respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      356
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      343
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      191
      num Events
      2
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      356
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      343
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Upper respiratory tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Abscess limb
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      191
      num Events
      1
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      343
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Biliary tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      343
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      191
      num Events
      1
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      356
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      343
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      191
      num Events
      0
    term
    Cellulitis
time Frame
From signing of first informed consent up to 94 months.

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

Preserved source evidence · Not medical advice