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NCT04472429 · ADVERSE EVENTS

Adverse events

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). · Source last updated 2026-09-02

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
up to approximately 57 months
Other-event reporting threshold
5%

Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo + Chemotherapy

Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.

59 / 152151 / 15297 / 152
Retifanlimab 500 mg Q4W + Chemotherapy

Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).

73 / 154154 / 15479 / 154
Randomized Period Total

Randomized Period Total

132 / 306305 / 306176 / 306
Retifanlimab 500 mg Q4W

In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).

19 / 7757 / 7754 / 77

Group identifiers: EG000: Placebo + Chemotherapy · EG001: Retifanlimab 500 mg Q4W + Chemotherapy · EG002: Randomized Period Total · EG003: Retifanlimab 500 mg Q4W

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      306
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      77
      num Events
      2
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      154
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      306
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      154
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      306
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      154
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      306
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      152
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      306
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Anal abscess
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      306
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Anal fistula
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      154
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Anal infection
  9. 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
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      154
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      154
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      154
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      306
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Asthenia

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
      18
      num At Risk
      152
      num Events
      22
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      154
      num Events
      19
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      306
      num Events
      41
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      77
      num Events
      7
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      152
      num Events
      25
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      154
      num Events
      18
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      306
      num Events
      43
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      152
      num Events
      10
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      154
      num Events
      21
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      306
      num Events
      31
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      77
      num Events
      4
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      152
      num Events
      76
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      154
      num Events
      83
    3. group Id
      EG002
      num Affected
      154
      num At Risk
      306
      num Events
      159
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Alopecia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      152
      num Events
      170
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      154
      num Events
      175
    3. group Id
      EG002
      num Affected
      207
      num At Risk
      306
      num Events
      345
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      77
      num Events
      11
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      152
      num Events
      11
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      154
      num Events
      12
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      306
      num Events
      23
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      152
      num Events
      29
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      154
      num Events
      31
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      306
      num Events
      60
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      77
      num Events
      4
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      152
      num Events
      12
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      154
      num Events
      18
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      306
      num Events
      30
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      77
      num Events
      7
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      152
      num Events
      104
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      154
      num Events
      109
    3. group Id
      EG002
      num Affected
      135
      num At Risk
      306
      num Events
      213
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      77
      num Events
      14
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      152
      num Events
      26
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      154
      num Events
      17
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      306
      num Events
      43
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      77
      num Events
      3
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      152
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      154
      num Events
      12
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      306
      num Events
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      77
      num Events
      2
    term
    Blood alkaline phosphatase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      154
      num Events
      10
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      306
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      77
      num Events
      3
    term
    Blood creatinine increased
Complete source fields
description
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
event Groups
  1. deaths Num Affected
    97
    deaths Num At Risk
    152
    description
    Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
    id
    EG000
    other Num Affected
    151
    other Num At Risk
    152
    serious Num Affected
    59
    serious Num At Risk
    152
    title
    Placebo + Chemotherapy
  2. deaths Num Affected
    79
    deaths Num At Risk
    154
    description
    Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
    id
    EG001
    other Num Affected
    154
    other Num At Risk
    154
    serious Num Affected
    73
    serious Num At Risk
    154
    title
    Retifanlimab 500 mg Q4W + Chemotherapy
  3. deaths Num Affected
    176
    deaths Num At Risk
    306
    description
    Randomized Period Total
    id
    EG002
    other Num Affected
    305
    other Num At Risk
    306
    serious Num Affected
    132
    serious Num At Risk
    306
    title
    Randomized Period Total
  4. deaths Num Affected
    54
    deaths Num At Risk
    77
    description
    In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
    id
    EG003
    other Num Affected
    57
    other Num At Risk
    77
    serious Num Affected
    19
    serious Num At Risk
    77
    title
    Retifanlimab 500 mg Q4W
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
      18
      num At Risk
      152
      num Events
      22
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      154
      num Events
      19
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      306
      num Events
      41
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      77
      num Events
      7
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      152
      num Events
      25
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      154
      num Events
      18
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      306
      num Events
      43
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      152
      num Events
      10
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      154
      num Events
      21
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      306
      num Events
      31
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      77
      num Events
      4
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      152
      num Events
      76
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      154
      num Events
      83
    3. group Id
      EG002
      num Affected
      154
      num At Risk
      306
      num Events
      159
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Alopecia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      152
      num Events
      170
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      154
      num Events
      175
    3. group Id
      EG002
      num Affected
      207
      num At Risk
      306
      num Events
      345
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      77
      num Events
      11
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      152
      num Events
      11
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      154
      num Events
      12
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      306
      num Events
      23
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      152
      num Events
      29
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      154
      num Events
      31
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      306
      num Events
      60
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      77
      num Events
      4
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      152
      num Events
      12
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      154
      num Events
      18
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      306
      num Events
      30
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      77
      num Events
      7
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      152
      num Events
      104
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      154
      num Events
      109
    3. group Id
      EG002
      num Affected
      135
      num At Risk
      306
      num Events
      213
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      77
      num Events
      14
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      152
      num Events
      26
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      154
      num Events
      17
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      306
      num Events
      43
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      77
      num Events
      3
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      152
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      154
      num Events
      12
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      306
      num Events
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      77
      num Events
      2
    term
    Blood alkaline phosphatase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      154
      num Events
      10
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      306
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      77
      num Events
      3
    term
    Blood creatinine increased
serious Events
  1. 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
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      306
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      77
      num Events
      2
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      154
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      306
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      154
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      306
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      154
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      306
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      152
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      306
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Anal abscess
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      306
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Anal fistula
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      154
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Anal infection
  9. 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
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      154
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      154
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      154
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      306
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      154
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      306
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Asthenia
time Frame
up to approximately 57 months

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Preserved source evidence · Not medical advice