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NCT05256381 · ADVERSE EVENTS

Adverse events

A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors · Source last updated 2025-11-17

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
Day 1 up to approximately 2 years and 2 months
Other-event reporting threshold
5%

Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Non-small Cell Lung Cancer

Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment

23 / 4040 / 4017 / 40
Colorectal Cancer

Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic

3 / 88 / 83 / 8
Cutaneous Squamous Cell Carcinoma

Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

3 / 1212 / 124 / 12
Hepatocellular Carcinoma

Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

3 / 1212 / 125 / 12
Metastatic Castration-resistant Prostate Cancer

Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

28 / 5454 / 5424 / 55
Ovarian Cancer

Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months

28 / 3939 / 3921 / 39

Group identifiers: EG000: Non-small Cell Lung Cancer · EG001: Colorectal Cancer · EG002: Cutaneous Squamous Cell Carcinoma · EG003: Hepatocellular Carcinoma · EG004: Metastatic Castration-resistant Prostate Cancer · EG005: Ovarian Cancer

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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      54
      num Events
      7
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      39
      num Events
      6
    term
    Malignant neoplasm progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      54
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Cancer pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hypotension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Jugular vein thrombosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      54
      num Events
      7
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      39
      num Events
      14
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      54
      num Events
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
      num Events
      3
    term
    General physical health deterioration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
      num Events
      3
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    2 SAEs were classified by the investigator as Unknown cause of death. Both were coded per MedDRA as General disorders and administration site conditions/Death.
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Death
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Discomfort
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Multiple organ dysfunction syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      54
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Non-cardiac chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      2
    term
    Oedema peripheral

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      40
      num Events
      26
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      12
      num Events
      10
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      12
      num Events
      14
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      54
      num Events
      42
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      39
      num Events
      9
    term
    Lymphocyte count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      40
      num Events
      23
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      5
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      54
      num Events
      30
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      39
      num Events
      10
    term
    Aspartate aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      40
      num Events
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      54
      num Events
      17
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      39
      num Events
      11
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      12
      num Events
      4
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      54
      num Events
      9
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
      num Events
      5
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      3
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      54
      num Events
      24
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
      num Events
      10
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      12
      num Events
      6
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      54
      num Events
      32
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      4
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      54
      num Events
      17
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
      num Events
      6
    term
    Blood creatinine increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      54
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Blood alkaline phosphatase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      54
      num Events
      13
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      39
      num Events
      4
    term
    Amylase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      54
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Weight decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      54
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Lipase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      54
      num Events
      43
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      39
      num Events
      5
    term
    Hypotension
Complete source fields
description
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    40
    description
    Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    23
    serious Num At Risk
    40
    title
    Non-small Cell Lung Cancer
  2. deaths Num Affected
    3
    deaths Num At Risk
    8
    description
    Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Colorectal Cancer
  3. deaths Num Affected
    4
    deaths Num At Risk
    12
    description
    Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Cutaneous Squamous Cell Carcinoma
  4. deaths Num Affected
    5
    deaths Num At Risk
    12
    description
    Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
    id
    EG003
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Hepatocellular Carcinoma
  5. deaths Num Affected
    24
    deaths Num At Risk
    55
    description
    Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
    id
    EG004
    other Num Affected
    54
    other Num At Risk
    54
    serious Num Affected
    28
    serious Num At Risk
    54
    title
    Metastatic Castration-resistant Prostate Cancer
  6. deaths Num Affected
    21
    deaths Num At Risk
    39
    description
    Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
    id
    EG005
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    28
    serious Num At Risk
    39
    title
    Ovarian Cancer
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      40
      num Events
      26
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      12
      num Events
      10
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      12
      num Events
      14
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      54
      num Events
      42
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      39
      num Events
      9
    term
    Lymphocyte count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      40
      num Events
      23
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      5
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      54
      num Events
      30
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      39
      num Events
      10
    term
    Aspartate aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      40
      num Events
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      54
      num Events
      17
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      39
      num Events
      11
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      12
      num Events
      4
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      54
      num Events
      9
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
      num Events
      5
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      3
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      54
      num Events
      24
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
      num Events
      10
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      12
      num Events
      6
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      54
      num Events
      32
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      4
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      54
      num Events
      17
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
      num Events
      6
    term
    Blood creatinine increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      54
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Blood alkaline phosphatase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      54
      num Events
      13
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      39
      num Events
      4
    term
    Amylase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      54
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Weight decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      54
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Lipase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      54
      num Events
      43
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      39
      num Events
      5
    term
    Hypotension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      54
      num Events
      7
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      39
      num Events
      6
    term
    Malignant neoplasm progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      54
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Cancer pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hypotension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Jugular vein thrombosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      54
      num Events
      7
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      39
      num Events
      14
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      54
      num Events
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
      num Events
      3
    term
    General physical health deterioration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
      num Events
      3
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    2 SAEs were classified by the investigator as Unknown cause of death. Both were coded per MedDRA as General disorders and administration site conditions/Death.
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Death
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Discomfort
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Multiple organ dysfunction syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      54
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Non-cardiac chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      54
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
      num Events
      2
    term
    Oedema peripheral
time Frame
Day 1 up to approximately 2 years and 2 months

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Preserved source evidence · Not medical advice