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NCT05028374 · ADVERSE EVENTS

Adverse events

COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies · Source last updated 2023-12-20

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
Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1

Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.

0 / 5248 / 526 / 52
Cohort 2

Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.

0 / 5047 / 504 / 50
Cohort 3

Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.

1 / 1616 / 162 / 16

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2 · EG002: Cohort 3

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
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypercalcemia

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cardiac disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Ear and labyrinth disorders - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hearing impaired
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Tinnitus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Blurred vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Eye disorders - Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Eye pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Diarrhea
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    52
    description
    Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    52
    serious Num Affected
    0
    serious Num At Risk
    52
    title
    Cohort 1
  2. deaths Num Affected
    4
    deaths Num At Risk
    50
    description
    Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
    id
    EG001
    other Num Affected
    47
    other Num At Risk
    50
    serious Num Affected
    0
    serious Num At Risk
    50
    title
    Cohort 2
  3. deaths Num Affected
    2
    deaths Num At Risk
    16
    description
    Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
    id
    EG002
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    1
    serious Num At Risk
    16
    title
    Cohort 3
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cardiac disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Ear and labyrinth disorders - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hearing impaired
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Tinnitus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Blurred vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Eye disorders - Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Eye pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypercalcemia
time Frame
Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.

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