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NCT00819169 · ADVERSE EVENTS

Adverse events

QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors · Source last updated 2024-08-20

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 serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Other-event reporting threshold
5%

Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1 Cohort 1

AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

2 / 33 / 31 / 3
Part 1 Cohort 2

AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

0 / 33 / 31 / 3
Part 1 Cohort 3

AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

2 / 33 / 33 / 3
Part 2 Cohort 1

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC

3 / 1515 / 158 / 15
Part 2 Cohort 2

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC

6 / 77 / 75 / 8
Part 2 Cohort 3

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC

2 / 1615 / 167 / 16
Part 2 Cohort 4

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer

3 / 1614 / 169 / 16
Part 2 Cohort 5

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer

3 / 99 / 94 / 9
Part 2 Cohort 6

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma

2 / 1511 / 157 / 16

Group identifiers: EG000: Part 1 Cohort 1 · EG001: Part 1 Cohort 2 · EG002: Part 1 Cohort 3 · EG003: Part 2 Cohort 1 · EG004: Part 2 Cohort 2 · EG005: Part 2 Cohort 3 · EG006: Part 2 Cohort 4 · EG007: Part 2 Cohort 5 · EG008: Part 2 Cohort 6

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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Dyspnoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Pericardial Effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Ileus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Metastases To Small Intestine
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Small Intestinal Obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Abdominal Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      15
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      15
    term
    Gastrointestinal Haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Intestinal Obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Vomiting

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Pericardial Effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Sinus Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Abdominal Distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Abdominal Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      15
    term
    Abdominal Pain Upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      15
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Dyspepsia
Complete source fields
description
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Part 1 Cohort 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Part 1 Cohort 2
  3. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Part 1 Cohort 3
  4. deaths Num Affected
    8
    deaths Num At Risk
    15
    description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
    id
    EG003
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    3
    serious Num At Risk
    15
    title
    Part 2 Cohort 1
  5. deaths Num Affected
    5
    deaths Num At Risk
    8
    description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC
    id
    EG004
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    Part 2 Cohort 2
  6. deaths Num Affected
    7
    deaths Num At Risk
    16
    description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC
    id
    EG005
    other Num Affected
    15
    other Num At Risk
    16
    serious Num Affected
    2
    serious Num At Risk
    16
    title
    Part 2 Cohort 3
  7. deaths Num Affected
    9
    deaths Num At Risk
    16
    description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
    id
    EG006
    other Num Affected
    14
    other Num At Risk
    16
    serious Num Affected
    3
    serious Num At Risk
    16
    title
    Part 2 Cohort 4
  8. deaths Num Affected
    4
    deaths Num At Risk
    9
    description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
    id
    EG007
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    3
    serious Num At Risk
    9
    title
    Part 2 Cohort 5
  9. deaths Num Affected
    7
    deaths Num At Risk
    16
    description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
    id
    EG008
    other Num Affected
    11
    other Num At Risk
    15
    serious Num Affected
    2
    serious Num At Risk
    15
    title
    Part 2 Cohort 6
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Pericardial Effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Sinus Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Abdominal Distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Abdominal Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      15
    term
    Abdominal Pain Upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      15
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Dyspnoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Pericardial Effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Ileus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Metastases To Small Intestine
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Small Intestinal Obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Abdominal Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      15
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      15
    term
    Gastrointestinal Haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Intestinal Obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      15
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      16
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      15
    term
    Vomiting
time Frame
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.

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Preserved source evidence · Not medical advice