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NCT02082977 · ADVERSE EVENTS

Adverse events

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma · Source last updated 2020-02-25

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
Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years.
Other-event reporting threshold
5%

SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1:GSK2816126 50 mg Twice-weekly

Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

1 / 22 / 21 / 2
Part 1:GSK2816126 100 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

0 / 11 / 10 / 1
Part 1:GSK2816126 200 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

0 / 11 / 10 / 1
Part 1:GSK2816126 400 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

0 / 11 / 10 / 1
Part 1:GSK2816126 800 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

1 / 33 / 30 / 3
Part 1:GSK2816126 1200 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

2 / 44 / 41 / 4
Part 1:GSK2816126 1800 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

1 / 1010 / 102 / 10
Part 1:GSK2816126 2400 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

5 / 1212 / 120 / 12
Part 1:GSK2816126 3000 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

3 / 77 / 71 / 7
Part 2: All Participants

Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .

0 / 00 / 00 / 0

Group identifiers: EG000: Part 1:GSK2816126 50 mg Twice-weekly · EG001: Part 1:GSK2816126 100 mg Twice-weekly · EG002: Part 1:GSK2816126 200 mg Twice-weekly · EG003: Part 1:GSK2816126 400 mg Twice-weekly · EG004: Part 1:GSK2816126 800 mg Twice-weekly · EG005: Part 1:GSK2816126 1200 mg Twice-weekly · EG006: Part 1:GSK2816126 1800 mg Twice-weekly · EG007: Part 1:GSK2816126 2400 mg Twice-weekly · EG008: Part 1:GSK2816126 3000 mg Twice-weekly · EG009: Part 2: All Participants

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
    General disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Back pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Campylobacter infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Enterocolitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Haemoptysis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hypokalaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Intestinal obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Skin bacterial infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Tumour pain

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
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
      num Events
      2
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      10
      num Events
      6
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      12
      num Events
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      7
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      6
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      12
      num Events
      10
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      7
      num Events
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      5
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      12
      num Events
      6
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      7
      num Events
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      3
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      12
      num Events
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      7
      num Events
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      10
      num Events
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Cough
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      12
      num Events
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      7
      num Events
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      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
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      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
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      7
      num Events
      11
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Infusion related reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Decreased appetite
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      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
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hyperglycaemia
Complete source fields
description
SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Part 1:GSK2816126 50 mg Twice-weekly
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part 1:GSK2816126 100 mg Twice-weekly
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part 1:GSK2816126 200 mg Twice-weekly
  4. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part 1:GSK2816126 400 mg Twice-weekly
  5. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part 1:GSK2816126 800 mg Twice-weekly
  6. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG005
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Part 1:GSK2816126 1200 mg Twice-weekly
  7. deaths Num Affected
    2
    deaths Num At Risk
    10
    description
    Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG006
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    1
    serious Num At Risk
    10
    title
    Part 1:GSK2816126 1800 mg Twice-weekly
  8. deaths Num Affected
    0
    deaths Num At Risk
    12
    description
    Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG007
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    5
    serious Num At Risk
    12
    title
    Part 1:GSK2816126 2400 mg Twice-weekly
  9. deaths Num Affected
    1
    deaths Num At Risk
    7
    description
    Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    EG008
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Part 1:GSK2816126 3000 mg Twice-weekly
  10. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
    id
    EG009
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Part 2: All Participants
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
      num Events
      2
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      10
      num Events
      6
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      12
      num Events
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      7
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      6
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      12
      num Events
      10
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      7
      num Events
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      5
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      12
      num Events
      6
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      7
      num Events
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
      num Events
      3
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      12
      num Events
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      7
      num Events
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      10
      num Events
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Cough
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      12
      num Events
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      7
      num Events
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      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
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      10
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      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
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      7
      num Events
      11
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Infusion related reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Decreased appetite
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      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
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hyperglycaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      7
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Back pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Campylobacter infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Enterocolitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Haemoptysis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hypokalaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Intestinal obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Skin bacterial infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      7
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Tumour pain
time Frame
Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years.

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Preserved source evidence · Not medical advice