Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02659631 · ADVERSE EVENTS

Adverse events

PF-06671008 Dose Escalation Study in Advanced Solid Tumors · Source last updated 2020-05-06

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
For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
Other-event reporting threshold
5%

The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PF-06671008 1.5 ng/kg IV

PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

0 / 11 / 11 / 1
PF-06671008 7.5 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.

1 / 22 / 22 / 2
PF-06671008 20 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

1 / 33 / 31 / 3
PF-06671008 50 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.

2 / 22 / 21 / 2
PF-06671008 100 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

4 / 44 / 44 / 4
PF-06671008 200 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.

4 / 55 / 52 / 5
PF-06671008 300 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

3 / 44 / 41 / 4
PF-06671008 400 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.

2 / 33 / 33 / 3
PF-06671008 200 ng/kg SC

PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.

0 / 22 / 21 / 2
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.

0 / 11 / 10 / 1

Group identifiers: EG000: PF-06671008 1.5 ng/kg IV · EG001: PF-06671008 7.5 ng/kg IV · EG002: PF-06671008 20 ng/kg IV · EG003: PF-06671008 50 ng/kg IV · EG004: PF-06671008 100 ng/kg IV · EG005: PF-06671008 200 ng/kg IV · EG006: PF-06671008 300 ng/kg IV · EG007: PF-06671008 400 ng/kg IV · EG008: PF-06671008 200 ng/kg SC · EG009: PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Cytokine release syndrome
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Neoplasm progression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Rectal adenocarcinoma
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Pneumonitis

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Palpitations
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Sinus arrhythmia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      1
    term
    Tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Ventricular arrhythmia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Tinnitus
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Vertigo
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Periorbital oedema
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Vision blurred
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain upper
Complete source fields
description
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    PF-06671008 1.5 ng/kg IV
  2. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    PF-06671008 7.5 ng/kg IV
  3. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    PF-06671008 20 ng/kg IV
  4. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    PF-06671008 50 ng/kg IV
  5. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    4
    serious Num At Risk
    4
    title
    PF-06671008 100 ng/kg IV
  6. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    PF-06671008 200 ng/kg IV
  7. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    PF-06671008 300 ng/kg IV
  8. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    EG007
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    PF-06671008 400 ng/kg IV
  9. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
    id
    EG008
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    PF-06671008 200 ng/kg SC
  10. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    EG009
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Palpitations
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Sinus arrhythmia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      1
    term
    Tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Ventricular arrhythmia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Tinnitus
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Vertigo
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Periorbital oedema
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Vision blurred
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Cytokine release syndrome
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Neoplasm progression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Rectal adenocarcinoma
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      1
    term
    Pneumonitis
time Frame
For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice