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NCT02675452 · OUTCOME

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia · Source last updated 2025-07-09

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1 cycle 1 to 30 days after the last dose of AMG 176; median treatment duration was 1.2 months

What was measured

An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of investigational product (AMG 176) up to 30 days after the end of investigational product. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests were reported as TEAEs. A treatment-related AE was any TEAE that per investigator review had a reasonable possibility of being caused by the investigational product (AMG 176).

Analysis population: The FAS included all participants that received at least 1 dose of AMG 176.

Groups in this outcome

Part 1A Cohort 1 (MM): AMG 176 Dose A BIW

Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 2 (MM): AMG 176 Dose B BIW

Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 3 (MM): AMG 176 Dose C BIW

Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 4 (MM): AMG 176 Dose D BIW

Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 5 (MM): AMG 176 Dose E BIW

Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 6 (MM): AMG 176 Dose G BIW

Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW

Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW

Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW

Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW

Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW

Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW

Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW

Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW

Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3A Cohort 1 (AML): AMG 176 Dose D BIW

Participants with AML received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3A Cohort 2 (AML): AMG 176 Dose E BIW

Participants with AML received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW

Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW

Japanese participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3B Cohort 1 (AML): AMG 176 Dose E QW

Participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW

Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW

Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW

Japanese participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.

Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole

Participants with AML received AMG 176 Dose D QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 200 mg itraconazole QD for 7 days in week 1.

Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine

Participants with AML received AMG 176 Dose D QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.

Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine

Participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.

Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine

Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.

Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine

Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.

Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine

Participants with AML received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.

Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine

Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1A Cohort 1 (MM): AMG 176 Dose A BIW3
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW3
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW4
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW3
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW3
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW2
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW4
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW4
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW5
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW5
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW3
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW3
Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW3
Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW3
Part 3A Cohort 1 (AML): AMG 176 Dose D BIW5
Part 3A Cohort 2 (AML): AMG 176 Dose E BIW5
Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW5
Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW2
Part 3B Cohort 1 (AML): AMG 176 Dose E QW4
Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW3
Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW4
Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW4
Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole10
Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine5
Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine4
Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine4
Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine13
Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine10
Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine13

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1A Cohort 1 (MM): AMG 176 Dose A BIW3Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW2Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW4Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW3Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW3Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW2Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW4Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW4Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW5Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW5Not reportedNot reportedNot reportedNot reported
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW3Not reportedNot reportedNot reportedNot reported
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW3Not reportedNot reportedNot reportedNot reported
Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW3Not reportedNot reportedNot reportedNot reported
Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW3Not reportedNot reportedNot reportedNot reported
Part 3A Cohort 1 (AML): AMG 176 Dose D BIW5Not reportedNot reportedNot reportedNot reported
Part 3A Cohort 2 (AML): AMG 176 Dose E BIW5Not reportedNot reportedNot reportedNot reported
Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW5Not reportedNot reportedNot reportedNot reported
Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW2Not reportedNot reportedNot reportedNot reported
Part 3B Cohort 1 (AML): AMG 176 Dose E QW4Not reportedNot reportedNot reportedNot reported
Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW3Not reportedNot reportedNot reportedNot reported
Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW4Not reportedNot reportedNot reportedNot reported
Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW4Not reportedNot reportedNot reportedNot reported
Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole10Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine5Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine4Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine4Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine13Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine10Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine13Not reportedNot reportedNot reportedNot reported
Treatment-related TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1A Cohort 1 (MM): AMG 176 Dose A BIW2Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW1Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW3Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW3Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW3Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW2Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW3Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW2Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW5Not reportedNot reportedNot reportedNot reported
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW5Not reportedNot reportedNot reportedNot reported
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW3Not reportedNot reportedNot reportedNot reported
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW3Not reportedNot reportedNot reportedNot reported
Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW3Not reportedNot reportedNot reportedNot reported
Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW3Not reportedNot reportedNot reportedNot reported
Part 3A Cohort 1 (AML): AMG 176 Dose D BIW3Not reportedNot reportedNot reportedNot reported
Part 3A Cohort 2 (AML): AMG 176 Dose E BIW3Not reportedNot reportedNot reportedNot reported
Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW4Not reportedNot reportedNot reportedNot reported
Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW2Not reportedNot reportedNot reportedNot reported
Part 3B Cohort 1 (AML): AMG 176 Dose E QW2Not reportedNot reportedNot reportedNot reported
Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW3Not reportedNot reportedNot reportedNot reported
Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW2Not reportedNot reportedNot reportedNot reported
Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW3Not reportedNot reportedNot reportedNot reported
Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole5Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine5Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine4Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine4Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine11Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine8Not reportedNot reportedNot reportedNot reported
Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        5
      11. group Id
        OG010
        value
        3
      12. group Id
        OG011
        value
        3
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        5
      11. group Id
        OG010
        value
        3
      12. group Id
        OG011
        value
        3
    title
    Treatment-related TEAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      2
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      4
    9. group Id
      OG008
      value
      5
    10. group Id
      OG009
      value
      5
    11. group Id
      OG010
      value
      3
    12. group Id
      OG011
      value
      3
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of investigational product (AMG 176) up to 30 days after the end of investigational product. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests were reported as TEAEs. A treatment-related AE was any TEAE that per investigator review had a reasonable possibility of being caused by the investigational product (AMG 176).
groups
  1. description
    Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG000
    title
    Part 1A Cohort 1 (MM): AMG 176 Dose A BIW
  2. description
    Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG001
    title
    Part 1A Cohort 2 (MM): AMG 176 Dose B BIW
  3. description
    Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG002
    title
    Part 1A Cohort 3 (MM): AMG 176 Dose C BIW
  4. description
    Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG003
    title
    Part 1A Cohort 4 (MM): AMG 176 Dose D BIW
  5. description
    Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG004
    title
    Part 1A Cohort 5 (MM): AMG 176 Dose E BIW
  6. description
    Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG005
    title
    Part 1A Cohort 6 (MM): AMG 176 Dose G BIW
  7. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG006
    title
    Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW
  8. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG007
    title
    Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW
  9. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG008
    title
    Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW
  10. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG009
    title
    Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW
  11. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG010
    title
    Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW
  12. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    OG011
    title
    Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW
param Type
COUNT_OF_PARTICIPANTS
population Description
The FAS included all participants that received at least 1 dose of AMG 176.
reporting Status
POSTED
time Frame
Day 1 cycle 1 to 30 days after the last dose of AMG 176; median treatment duration was 1.2 months
title
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
type
PRIMARY
unit Of Measure
Participants

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