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NCT04101331 · ADVERSE EVENTS

Adverse events

Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides · Source last updated 2024-11-05

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
From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
Other-event reporting threshold
5%

The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

44 / 10895 / 10852 / 108

Group identifiers: EG000: Cohort A

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 Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      108
    term
    COVID-19
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      108
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
    term
    Herpes zoster
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
    term
    Septic shock
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    COVID-19 pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Clostridium difficile colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Cytomegalovirus infection reactivation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Enterococcal bacteraemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Orchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Periodontitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Pneumonia aspiration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Respiratory tract infection

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 Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      108
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      108
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      108
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      108
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      108
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      108
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      108
    term
    Rash
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      108
    term
    Erythema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      108
    term
    Pruritus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      108
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      108
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      108
    term
    Thrombocytopenia
Complete source fields
description
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
event Groups
  1. deaths Num Affected
    52
    deaths Num At Risk
    108
    description
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    id
    EG000
    other Num Affected
    95
    other Num At Risk
    108
    serious Num Affected
    44
    serious Num At Risk
    108
    title
    Cohort A
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      108
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      108
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      108
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      108
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      108
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      108
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      108
    term
    Rash
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      108
    term
    Erythema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      108
    term
    Pruritus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      108
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      108
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      108
    term
    Thrombocytopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      108
    term
    COVID-19
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      108
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
    term
    Herpes zoster
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
    term
    Septic shock
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    COVID-19 pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Clostridium difficile colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Cytomegalovirus infection reactivation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Enterococcal bacteraemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Orchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Periodontitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Pneumonia aspiration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Respiratory tract infection
time Frame
From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.

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Preserved source evidence · Not medical advice