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NCT03525678 · ADVERSE EVENTS

Adverse events

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody · Source last updated 2025-09-03

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

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

Collection time frame
All-cause mortality, Serious adverse events (SAEs) and (>=5%) non-serious AEs (Non-SAEs) were collected from the start of study treatment until maximum of 186 weeks for main study and up to approximately 325 weeks for PACT phase.
Other-event reporting threshold
5%

SAEs \& non-SAEs for Full Safety Population comprised all participants who received atleast 1 dose of treatment.3 out of 221 participants didn't receive treatment \& thus excluded from reporting. All-cause mortality for Full Safety Population comprised all randomized participants whether or not randomized treatment was administered.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

43 / 9593 / 9570 / 97
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

53 / 9996 / 9980 / 99
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.

15 / 2424 / 2416 / 25
PACT Phase: GSK2857916 2.5 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks up to approximately 101 weeks. Frozen liquid was diluted with 0.9 percent saline.

1 / 10 / 10 / 1
PACT Phase: GSK2857916 3.4 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks up to approximately 101 weeks. Frozen liquid was diluted with 0.9 percent saline.

2 / 20 / 20 / 2

Group identifiers: EG000: Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) · EG001: Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) · EG002: Main Study: GSK2857916 3.4 mg/kg (Lyophilized) · EG003: PACT Phase: GSK2857916 2.5 mg/kg (Frozen Liquid) · EG004: PACT Phase: GSK2857916 3.4 mg/kg (Frozen Liquid)

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      95
      num Events
      8
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      99
      num Events
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      95
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      24
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      95
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Hypercalcaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      95
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Infusion related reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      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
      2
      num Events
      1
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      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
      2
      num Events
      1
    term
    Gastrointestinal haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Pleural effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Acute kidney injury
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Cellulitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Cerebral haemorrhage

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
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      95
      num Events
      267
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      99
      num Events
      320
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      24
      num Events
      100
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Keratopathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      95
      num Events
      34
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      99
      num Events
      73
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      24
      num Events
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      95
      num Events
      28
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      99
      num Events
      49
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      24
      num Events
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      95
      num Events
      37
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      99
      num Events
      50
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      24
      num Events
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Vision blurred
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      95
      num Events
      29
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      99
      num Events
      40
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      95
      num Events
      19
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      99
      num Events
      37
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      24
      num Events
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      95
      num Events
      26
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      99
      num Events
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      24
      num Events
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      95
      num Events
      21
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      99
      num Events
      29
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      95
      num Events
      24
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      99
      num Events
      19
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      95
      num Events
      18
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      99
      num Events
      21
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Dry eye
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      95
      num Events
      16
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      99
      num Events
      21
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Decreased appetite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      95
      num Events
      12
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      99
      num Events
      24
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Upper respiratory tract infection
Complete source fields
description
SAEs \& non-SAEs for Full Safety Population comprised all participants who received atleast 1 dose of treatment.3 out of 221 participants didn't receive treatment \& thus excluded from reporting. All-cause mortality for Full Safety Population comprised all randomized participants whether or not randomized treatment was administered.
event Groups
  1. deaths Num Affected
    70
    deaths Num At Risk
    97
    description
    Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
    id
    EG000
    other Num Affected
    93
    other Num At Risk
    95
    serious Num Affected
    43
    serious Num At Risk
    95
    title
    Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
  2. deaths Num Affected
    80
    deaths Num At Risk
    99
    description
    Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
    id
    EG001
    other Num Affected
    96
    other Num At Risk
    99
    serious Num Affected
    53
    serious Num At Risk
    99
    title
    Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
  3. deaths Num Affected
    16
    deaths Num At Risk
    25
    description
    Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
    id
    EG002
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    15
    serious Num At Risk
    24
    title
    Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
  4. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks up to approximately 101 weeks. Frozen liquid was diluted with 0.9 percent saline.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    PACT Phase: GSK2857916 2.5 mg/kg (Frozen Liquid)
  5. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks up to approximately 101 weeks. Frozen liquid was diluted with 0.9 percent saline.
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    PACT Phase: GSK2857916 3.4 mg/kg (Frozen Liquid)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      95
      num Events
      267
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      99
      num Events
      320
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      24
      num Events
      100
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Keratopathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      95
      num Events
      34
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      99
      num Events
      73
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      24
      num Events
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      95
      num Events
      28
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      99
      num Events
      49
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      24
      num Events
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      95
      num Events
      37
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      99
      num Events
      50
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      24
      num Events
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Vision blurred
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      95
      num Events
      29
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      99
      num Events
      40
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      95
      num Events
      19
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      99
      num Events
      37
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      24
      num Events
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      95
      num Events
      26
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      99
      num Events
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      24
      num Events
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      95
      num Events
      21
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      99
      num Events
      29
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      95
      num Events
      24
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      99
      num Events
      19
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      95
      num Events
      18
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      99
      num Events
      21
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Dry eye
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      95
      num Events
      16
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      99
      num Events
      21
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Decreased appetite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      95
      num Events
      12
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      99
      num Events
      24
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Upper respiratory tract infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      95
      num Events
      8
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      99
      num Events
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      95
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      24
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      95
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Hypercalcaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      95
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Infusion related reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      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
      2
      num Events
      1
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      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
      2
      num Events
      1
    term
    Gastrointestinal haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Pleural effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Acute kidney injury
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Cellulitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    term
    Cerebral haemorrhage
time Frame
All-cause mortality, Serious adverse events (SAEs) and (>=5%) non-serious AEs (Non-SAEs) were collected from the start of study treatment until maximum of 186 weeks for main study and up to approximately 325 weeks for PACT phase.

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