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NCT03246529 · ADVERSE EVENTS

Adverse events

A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) · Source last updated 2026-01-15

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
All Adverse Events (AEs) were collected after subjects signed the ICF and up to 30 days from the last dose of study therapy (G-CSF+BL-8040/Placebo).
Other-event reporting threshold
5%

All AEs were collected after subjects signed the ICF and up to 30 days from the last dose of study therapy (G-CSF+BL-8040/Placebo). AE were followed by the investigators until their satisfactory resolution or stabilization. AE were recorded and graded according to the latest version of the NCI-CTCAE. All-cause mortality was reported across the entire study duration, including the 5 years follow-up phase.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
BL-8040 + G-CSF Part 1

Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Days 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.

1 / 1212 / 120 / 12
BL-8040 + G-CSF (Part 2)

Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.

7 / 8077 / 802 / 80
Placebo + G-CSF (Part 2)

Part 2 (randomized, double-blinded, placebo-controlled period). G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.

0 / 4235 / 421 / 42

Group identifiers: EG000: BL-8040 + G-CSF Part 1 · EG001: BL-8040 + G-CSF (Part 2) · EG002: Placebo + G-CSF (Part 2)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Injection site reaction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Hypersensitivity
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Bacteremia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Injection site cellulitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Platelet count decreased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Bladder neoplasm
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Hypoxia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Hypokalaemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Vomiting

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      80
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      42
      num Events
      7
    term
    Arthralgia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      80
      num Events
      17
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      42
      num Events
      10
    term
    Back pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      80
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      42
      num Events
      4
    term
    Musculoskeletal chest pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      80
      num Events
      15
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      42
      num Events
      18
    term
    Bone pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Spinal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Muscle spasms
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Ear discomfort
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Auricular swelling
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Catheter site bruise
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      80
      num Events
      9
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      42
      num Events
      6
    term
    Catheter site pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      80
      num Events
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      42
      num Events
      5
    term
    Chest pain
Complete source fields
description
All AEs were collected after subjects signed the ICF and up to 30 days from the last dose of study therapy (G-CSF+BL-8040/Placebo). AE were followed by the investigators until their satisfactory resolution or stabilization. AE were recorded and graded according to the latest version of the NCI-CTCAE. All-cause mortality was reported across the entire study duration, including the 5 years follow-up phase.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    12
    description
    Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Days 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    1
    serious Num At Risk
    12
    title
    BL-8040 + G-CSF Part 1
  2. deaths Num Affected
    2
    deaths Num At Risk
    80
    description
    Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    EG001
    other Num Affected
    77
    other Num At Risk
    80
    serious Num Affected
    7
    serious Num At Risk
    80
    title
    BL-8040 + G-CSF (Part 2)
  3. deaths Num Affected
    1
    deaths Num At Risk
    42
    description
    Part 2 (randomized, double-blinded, placebo-controlled period). G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    EG002
    other Num Affected
    35
    other Num At Risk
    42
    serious Num Affected
    0
    serious Num At Risk
    42
    title
    Placebo + G-CSF (Part 2)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      80
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      42
      num Events
      7
    term
    Arthralgia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      80
      num Events
      17
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      42
      num Events
      10
    term
    Back pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      80
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      42
      num Events
      4
    term
    Musculoskeletal chest pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      80
      num Events
      15
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      42
      num Events
      18
    term
    Bone pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Spinal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Muscle spasms
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Ear discomfort
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Auricular swelling
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Catheter site bruise
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      80
      num Events
      9
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      42
      num Events
      6
    term
    Catheter site pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      80
      num Events
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      42
      num Events
      5
    term
    Chest pain
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Injection site reaction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Hypersensitivity
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Bacteremia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Injection site cellulitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Platelet count decreased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Bladder neoplasm
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      80
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Hypoxia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Hypokalaemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      80
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Vomiting
time Frame
All Adverse Events (AEs) were collected after subjects signed the ICF and up to 30 days from the last dose of study therapy (G-CSF+BL-8040/Placebo).

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Preserved source evidence · Not medical advice