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NCT01930162 · ADVERSE EVENTS

Adverse events

Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant · Source last updated 2021-01-05

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
Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Other-event reporting threshold
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Time Period From Transplant Until 48hrs After Transplant

Adverse events that occurred within the first 48 hours of transplant.

0 / 98 / 9Not reported / Not reported
Time Period From Day 3 up to End of Study

Adverse Events that occurred 48 hours post-transplant.

9 / 96 / 9Not reported / Not reported

Group identifiers: EG000: Time Period From Transplant Until 48hrs After Transplant · EG001: Time Period From Day 3 up to End of Study

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Oesophageal achalasia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      9
    term
    Acute graft versus host disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Cellulitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
    term
    Clostridium difficile infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Cytomegalovirus viraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Human herpesvirus 6 infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Staphylococcal bacteraemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Staphylococcal sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Transplant failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Chronic lymphocytic leukaemia recurrent

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Cellulitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
    term
    Cytomegalovirus viraemia
Complete source fields
event Groups
  1. description
    Adverse events that occurred within the first 48 hours of transplant.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    0
    serious Num At Risk
    9
    title
    Time Period From Transplant Until 48hrs After Transplant
  2. description
    Adverse Events that occurred 48 hours post-transplant.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    9
    serious Num Affected
    9
    serious Num At Risk
    9
    title
    Time Period From Day 3 up to End of Study
frequency Threshold
1
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Cellulitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
    term
    Cytomegalovirus viraemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Oesophageal achalasia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      9
    term
    Acute graft versus host disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Cellulitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
    term
    Clostridium difficile infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Cytomegalovirus viraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Human herpesvirus 6 infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Staphylococcal bacteraemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Staphylococcal sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Transplant failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Chronic lymphocytic leukaemia recurrent
time Frame
Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.

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