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NCT00985959 · ADVERSE EVENTS

Adverse events

A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT) · Source last updated 2013-12-02

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
54 weeks
Other-event reporting threshold
5%

87 participants who received at least 1 dose of study medication were evaluated for safety.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I - JNJ-26866138 0.7 mg/m2 Group

JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

2 / 66 / 6Not reported / Not reported
Phase I - JNJ-26866138 1.0 mg/m2 Group

JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

2 / 66 / 6Not reported / Not reported
Phase I - JNJ-26866138 1.3 mg/m2 Group

JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

1 / 66 / 6Not reported / Not reported
Phase II - JNJ-26866138 1.3 mg/m2 Group

JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

29 / 8787 / 87Not reported / Not reported

Group identifiers: EG000: Phase I - JNJ-26866138 0.7 mg/m2 Group · EG001: Phase I - JNJ-26866138 1.0 mg/m2 Group · EG002: Phase I - JNJ-26866138 1.3 mg/m2 Group · EG003: Phase II - JNJ-26866138 1.3 mg/m2 Group

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Bronchopulmonary aspergillosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Herpes zoster
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Pneumonia pneumococcal
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Septic shock
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Upper respiratory tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Herpes zoster dissemin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Enterocolitis bacterial
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Gastric cancer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Thyroid cancer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Anaemia

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      87
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      87
    term
    Neutropenic infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      87
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      87
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      87
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      84
      num At Risk
      87
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      60
      num At Risk
      87
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      87
    term
    Leukocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      50
      num At Risk
      87
    term
    Decreased appetite
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      45
      num At Risk
      87
    term
    Hyponatraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      43
      num At Risk
      87
    term
    Hyperglycaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      42
      num At Risk
      87
    term
    Hypokalaemia
Complete source fields
description
87 participants who received at least 1 dose of study medication were evaluated for safety.
event Groups
  1. description
    JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase I - JNJ-26866138 0.7 mg/m2 Group
  2. description
    JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase I - JNJ-26866138 1.0 mg/m2 Group
  3. description
    JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Phase I - JNJ-26866138 1.3 mg/m2 Group
  4. description
    JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
    id
    EG003
    other Num Affected
    87
    other Num At Risk
    87
    serious Num Affected
    29
    serious Num At Risk
    87
    title
    Phase II - JNJ-26866138 1.3 mg/m2 Group
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      87
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      87
    term
    Neutropenic infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      87
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      87
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      87
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      84
      num At Risk
      87
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      60
      num At Risk
      87
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      87
    term
    Leukocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      50
      num At Risk
      87
    term
    Decreased appetite
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      45
      num At Risk
      87
    term
    Hyponatraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      43
      num At Risk
      87
    term
    Hyperglycaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      42
      num At Risk
      87
    term
    Hypokalaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Bronchopulmonary aspergillosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Herpes zoster
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Pneumonia pneumococcal
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Septic shock
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Upper respiratory tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Herpes zoster dissemin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Enterocolitis bacterial
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Gastric cancer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Thyroid cancer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Anaemia
time Frame
54 weeks

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Preserved source evidence · Not medical advice