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NCT00552396 · ADVERSE EVENTS

Adverse events

An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple Myeloma · Source last updated 2016-03-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse events were collected from screening and until the end of study at each study visit. Maximal study duration according to dose level was 4 to 9 months.
Other-event reporting threshold
5%

All participants who received at least one dose of the study drug (safety population).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
0.0003 mg/kg

3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.

1 / 44 / 4Not reported / Not reported
0.003 mg/kg

Not reported

0 / 33 / 3Not reported / Not reported
0.015 mg/kg

Not reported

0 / 33 / 3Not reported / Not reported
0.075 mg/kg

Not reported

5 / 66 / 6Not reported / Not reported
0.3 mg/kg

Not reported

0 / 33 / 3Not reported / Not reported
1 mg/kg

Not reported

0 / 33 / 3Not reported / Not reported
3 mg/kg

Not reported

3 / 1010 / 10Not reported / Not reported

Group identifiers: EG000: 0.0003 mg/kg · EG001: 0.003 mg/kg · EG002: 0.015 mg/kg · EG003: 0.075 mg/kg · EG004: 0.3 mg/kg · EG005: 1 mg/kg · EG006: 3 mg/kg

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
    Nervous system disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Headeache
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Non cardiac chest pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dyspnoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Decreased platelets
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Acute Renal failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Increased creatinine
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    progression of disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    worsening back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    worsening nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pneumonia

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
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      3
      num Events
      2
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    chills
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Non Cardiac chest pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    edema peripheral
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    upper respiratory tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pneumonia
Complete source fields
description
All participants who received at least one dose of the study drug (safety population).
event Groups
  1. description
    3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    0.0003 mg/kg
  2. id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    0.003 mg/kg
  3. id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    0.015 mg/kg
  4. id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    0.075 mg/kg
  5. id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    0.3 mg/kg
  6. id
    EG005
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    1 mg/kg
  7. id
    EG006
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    3
    serious Num At Risk
    10
    title
    3 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      3
      num Events
      2
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    chills
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Non Cardiac chest pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    edema peripheral
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    upper respiratory tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pneumonia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Headeache
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Non cardiac chest pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dyspnoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Decreased platelets
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Acute Renal failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Increased creatinine
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    progression of disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    worsening back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    worsening nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pneumonia
time Frame
Adverse events were collected from screening and until the end of study at each study visit. Maximal study duration according to dose level was 4 to 9 months.

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Preserved source evidence · Not medical advice