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NCT01794572 · ADVERSE EVENTS

Adverse events

Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse · Source last updated 2025-12-12

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
The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue.
Other-event reporting threshold
0%

The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Total Bone Marrow Irradiation (TBMI): 8 Gy

Cohort 1: Total Bone Marrow Irradiation (TBMI): 8 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.

1 / 33 / 30 / 3
Total Bone Marrow Irradiation (TBMI): 10 Gy

Cohort 2: Total Bone Marrow Irradiation (TBMI): 10 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.

1 / 33 / 30 / 3
Total Bone Marrow Irradiation (TBMI): 12 Gy

Cohort 3: Total Bone Marrow Irradiation (TBMI): 12 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.

2 / 66 / 60 / 6
Total Bone Marrow Irradiation (TBMI): 14 Gy

Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.

0 / 11 / 10 / 1
Total Bone Marrow Irradiation (TBMI): 16 Gy

Cohort 5: Total Bone Marrow Irradiation (TBMI): 16 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.

0 / 00 / 00 / 0

Group identifiers: EG000: Total Bone Marrow Irradiation (TBMI): 8 Gy · EG001: Total Bone Marrow Irradiation (TBMI): 10 Gy · EG002: Total Bone Marrow Irradiation (TBMI): 12 Gy · EG003: Total Bone Marrow Irradiation (TBMI): 14 Gy · EG004: Total Bone Marrow Irradiation (TBMI): 16 Gy

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
    notes
    Acute Grade 3 diarrhoea related to Melphalan
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Dyspnoea grade 3 related to anemia
    organ System
    Cardiac disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspnoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Septic shock grade 3 with febrile neutropenia
    organ System
    Infections and infestations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Septic shock
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Implanted-port-catheter-related sepsis caused by Staphylococcus aureus grade 3
    organ System
    Infections and infestations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Device related sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Severe cognitive distress associated to hypernatremia and febrile aplasia grade 3
    organ System
    Nervous system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Severe cognitive distress
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Febrile episode consistent with engraftment syndrome following stem cell transplantation, grade 3
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Interstitial lung disease with cytokine release syndrome grade 3
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Interstitial lung disease

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
    notes
    Grade 3 and 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num At Risk
      0
    term
    Thrombopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Sepsis due to Staphylococcus hominis, grade 3
    organ System
    Infections and infestations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num At Risk
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Mucositis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Febrile aplasia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num At Risk
      0
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Renal and urinary disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Cystitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Hypocalcemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Hypokalemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num At Risk
      0
    term
    Lymphopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Leucopenia
Complete source fields
description
The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Cohort 1: Total Bone Marrow Irradiation (TBMI): 8 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Total Bone Marrow Irradiation (TBMI): 8 Gy
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Cohort 2: Total Bone Marrow Irradiation (TBMI): 10 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Total Bone Marrow Irradiation (TBMI): 10 Gy
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Cohort 3: Total Bone Marrow Irradiation (TBMI): 12 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Total Bone Marrow Irradiation (TBMI): 12 Gy
  4. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Total Bone Marrow Irradiation (TBMI): 14 Gy
  5. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Cohort 5: Total Bone Marrow Irradiation (TBMI): 16 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue: re-infused in the central line on day "0" after adequate premedication.
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Total Bone Marrow Irradiation (TBMI): 16 Gy
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num At Risk
      0
    term
    Thrombopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Sepsis due to Staphylococcus hominis, grade 3
    organ System
    Infections and infestations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num At Risk
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Mucositis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Febrile aplasia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num At Risk
      0
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Renal and urinary disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Cystitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Hypocalcemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Hypokalemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num At Risk
      0
    term
    Lymphopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 to 4
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num At Risk
      0
    term
    Leucopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Acute Grade 3 diarrhoea related to Melphalan
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Dyspnoea grade 3 related to anemia
    organ System
    Cardiac disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspnoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Septic shock grade 3 with febrile neutropenia
    organ System
    Infections and infestations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Septic shock
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Implanted-port-catheter-related sepsis caused by Staphylococcus aureus grade 3
    organ System
    Infections and infestations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Device related sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Severe cognitive distress associated to hypernatremia and febrile aplasia grade 3
    organ System
    Nervous system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Severe cognitive distress
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Febrile episode consistent with engraftment syndrome following stem cell transplantation, grade 3
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Interstitial lung disease with cytokine release syndrome grade 3
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Interstitial lung disease
time Frame
The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue.

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