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NCT03599713 · ADVERSE EVENTS

Adverse events

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201) · Source last updated 2025-08-05

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
Deaths were assessed for up to 60.4 months. Adverse events were assessed for up to 846 days (up to approximately 2.3 years).
Other-event reporting threshold
5%

Treatment-emergent adverse events (TEAEs), defined as either AEs reported for the first time or worsening of pre-existing events after the first dose of study drug until 90 days after the last dose of study drug, are reported for members of the Safety Evaluable Population (all enrolled participants who received at least 1 dose of study drug). AEs with onset on/after starting a new anticancer therapy were not summarized as TEAEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemotherapy: Naïve

Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).

26 / 10183 / 10139 / 101
Chemotherapy: Refractory

Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.

2 / 65 / 63 / 6
Total

Total

28 / 10788 / 10742 / 107

Group identifiers: EG000: Chemotherapy: Naïve · EG001: Chemotherapy: Refractory · EG002: Total

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
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Acute myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Acute respiratory failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Amylase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      101
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
      num Events
      3
    term
    Asthenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      107
      num Events
      2
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Atrioventricular block
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Basal cell carcinoma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      107
      num Events
      2
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      101
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      107
      num Events
      4
    term
    COVID-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Colitis

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
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      101
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      107
      num Events
      8
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      101
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      107
      num Events
      11
    term
    Amylase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      101
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      107
      num Events
      7
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      101
      num Events
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      5
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      107
      num Events
      28
    term
    Arthralgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      101
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      107
      num Events
      7
    term
    Aspartate aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      101
      num Events
      24
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      107
      num Events
      27
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      101
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      107
      num Events
      7
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      101
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      107
      num Events
      8
    term
    Blood creatinine increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
      num Events
      3
    term
    Blood lactate dehydrogenase increased
  10. 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
      101
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      107
      num Events
      11
    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
      5
      num At Risk
      101
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      107
      num Events
      6
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      101
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      107
      num Events
      13
    term
    Constipation
Complete source fields
description
Treatment-emergent adverse events (TEAEs), defined as either AEs reported for the first time or worsening of pre-existing events after the first dose of study drug until 90 days after the last dose of study drug, are reported for members of the Safety Evaluable Population (all enrolled participants who received at least 1 dose of study drug). AEs with onset on/after starting a new anticancer therapy were not summarized as TEAEs.
event Groups
  1. deaths Num Affected
    39
    deaths Num At Risk
    101
    description
    Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
    id
    EG000
    other Num Affected
    83
    other Num At Risk
    101
    serious Num Affected
    26
    serious Num At Risk
    101
    title
    Chemotherapy: Naïve
  2. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Chemotherapy: Refractory
  3. deaths Num Affected
    42
    deaths Num At Risk
    107
    description
    Total
    id
    EG002
    other Num Affected
    88
    other Num At Risk
    107
    serious Num Affected
    28
    serious Num At Risk
    107
    title
    Total
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      101
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      107
      num Events
      8
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      101
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      107
      num Events
      11
    term
    Amylase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      101
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      107
      num Events
      7
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      101
      num Events
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      5
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      107
      num Events
      28
    term
    Arthralgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      101
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      107
      num Events
      7
    term
    Aspartate aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      101
      num Events
      24
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      107
      num Events
      27
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      101
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      107
      num Events
      7
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      101
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      107
      num Events
      8
    term
    Blood creatinine increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
      num Events
      3
    term
    Blood lactate dehydrogenase increased
  10. 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
      101
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      107
      num Events
      11
    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
      5
      num At Risk
      101
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      107
      num Events
      6
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      101
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      107
      num Events
      13
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Acute myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Acute respiratory failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Amylase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      101
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
      num Events
      3
    term
    Asthenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      107
      num Events
      2
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Atrioventricular block
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Basal cell carcinoma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      107
      num Events
      2
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      101
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      107
      num Events
      4
    term
    COVID-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Colitis
time Frame
Deaths were assessed for up to 60.4 months. Adverse events were assessed for up to 846 days (up to approximately 2.3 years).

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Preserved source evidence · Not medical advice