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NCT03894618 · ADVERSE EVENTS

Adverse events

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas · Source last updated 2025-04-02

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

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

Collection time frame
Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SL-279252 (0.0001 mg/kg S1)

0.0001 mg/kg of IV SL-279252 (Schedule 1)

0 / 11 / 11 / 1
SL-279252 (0.001 mg/kg S1)

0.001 mg/kg of IV SL-279252 (Schedule 1)

1 / 11 / 11 / 1
SL-279252 (0.003 mg/kg S1)

0.003 mg/kg of IV SL-279252 (Schedule 1)

0 / 22 / 22 / 2
SL-279252 (0.01 mg/kg S1)

0.01 mg/kg of IV SL-279252 (Schedule 1)

0 / 11 / 11 / 1
SL-279252 (0.03 mg/kg S1)

0.03 mg/kg of IV SL-279252 (Schedule 1)

0 / 22 / 20 / 2
SL-279252 (0.1 mg/kg S1)

0.1 mg/kg of IV SL-279252 (Schedule 1)

1 / 33 / 33 / 3
SL-279252 (0.3 mg/kg S1)

0.3 mg/kg of IV SL-279252 (Schedule 1)

1 / 44 / 44 / 4
SL-279252 (1.0 mg/kg S1)

1.0 mg/kg of IV SL-279252 (Schedule 1)

3 / 64 / 64 / 6
SL-279252 (3.0 mg/kg S1)

3.0 mg/kg of IV SL-279252 (Schedule 1)

1 / 66 / 65 / 6
SL-279252 (6.0 mg/kg S1)

6.0 mg/kg of IV SL-279252 (Schedule 1)

1 / 43 / 44 / 4
SL-279252 (12.0 mg/kg S1)

12.0 mg/kg of IV SL-279252 (Schedule 1)

0 / 44 / 42 / 4
SL-279252 (24.0 mg/kg S1)

24.0 mg/kg of IV SL-279252 (Schedule 1)

1 / 22 / 20 / 2
SL-279252 (0.3 mg/kg S2)

0.3 mg/kg of IV SL-279252 (Schedule 2)

0 / 44 / 42 / 4
SL-279252 (1.0 mg/kg S2)

1.0 mg/kg of IV SL-279252 (Schedule 2)

2 / 65 / 65 / 6
SL-279252 (3.0 mg/kg S2)

3.0 mg/kg of IV SL-279252 (Schedule 2)

1 / 33 / 33 / 3

Group identifiers: EG000: SL-279252 (0.0001 mg/kg S1) · EG001: SL-279252 (0.001 mg/kg S1) · EG002: SL-279252 (0.003 mg/kg S1) · EG003: SL-279252 (0.01 mg/kg S1) · EG004: SL-279252 (0.03 mg/kg S1) · EG005: SL-279252 (0.1 mg/kg S1) · EG006: SL-279252 (0.3 mg/kg S1) · EG007: SL-279252 (1.0 mg/kg S1) · EG008: SL-279252 (3.0 mg/kg S1) · EG009: SL-279252 (6.0 mg/kg S1) · EG010: SL-279252 (12.0 mg/kg S1) · EG011: SL-279252 (24.0 mg/kg S1) · EG012: SL-279252 (0.3 mg/kg S2) · EG013: SL-279252 (1.0 mg/kg S2) · EG014: SL-279252 (3.0 mg/kg S2)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    acetabulum fracture
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    acute respiratory failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    cancer pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    diffuse large B-cell lymphoma
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    haemorrhage intracranial
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    hemiparesis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    infected neoplasm
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    inguinal hernia, obstructive
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    mouth haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    pleural effusion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    respiratory tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    seizure

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    constipation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    decreased appetite
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    back pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      2
    term
    infusion related reaction
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    insomnia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    cough
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    fatigue
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      2
    term
    rash maculo-papular
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    dehydration
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    0.0001 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    SL-279252 (0.0001 mg/kg S1)
  2. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    0.001 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    SL-279252 (0.001 mg/kg S1)
  3. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    0.003 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    SL-279252 (0.003 mg/kg S1)
  4. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    0.01 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    SL-279252 (0.01 mg/kg S1)
  5. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    0.03 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    SL-279252 (0.03 mg/kg S1)
  6. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    0.1 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG005
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    SL-279252 (0.1 mg/kg S1)
  7. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    0.3 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    SL-279252 (0.3 mg/kg S1)
  8. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    1.0 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG007
    other Num Affected
    4
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    SL-279252 (1.0 mg/kg S1)
  9. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    3.0 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG008
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    SL-279252 (3.0 mg/kg S1)
  10. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    6.0 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG009
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    SL-279252 (6.0 mg/kg S1)
  11. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    12.0 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG010
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    SL-279252 (12.0 mg/kg S1)
  12. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    24.0 mg/kg of IV SL-279252 (Schedule 1)
    id
    EG011
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    SL-279252 (24.0 mg/kg S1)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    constipation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    decreased appetite
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    back pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      2
    term
    infusion related reaction
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    insomnia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    cough
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    fatigue
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      2
    term
    rash maculo-papular
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    dehydration
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    acetabulum fracture
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    acute respiratory failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    cancer pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    diffuse large B-cell lymphoma
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    haemorrhage intracranial
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    hemiparesis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    infected neoplasm
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    inguinal hernia, obstructive
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    mouth haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    pleural effusion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    respiratory tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      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
      2
      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
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    seizure
time Frame
Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.

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