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NCT02773030 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI)

A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma · Source last updated 2026-03-20

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
Approximately on average of (Cohort A: 16.23 Cohort B: 10.32 Cohort D: 18.68 Cohort E: 15.65 Cohort F: 12.66 Cohort G: 16.03 Cohort H1: 17.22 Cohort H2: 21.07 Cohort I: 17.10 Cohort J: 20.56 Cohort K: 13.56) Months

What was measured

An adverse event of special interest (AESI) is one of scientific and medical interest specific to understanding the safety profile of the Investigational Product, CC-220, and may require close monitoring and rapid communication by the Investigator to the Sponsor. An AESI may be serious or nonserious. The rapid reporting of AESIs allows ongoing surveillance of these events in order to characterize and understand their association with the use of this investigational product.

Analysis population: Safety Population with Secondary Primary Malignancies. Cohorts H1, H2 and I did not have SPMs

Groups in this outcome

Cohort A: Treatment 1

CC220 0.30mg

Cohort A: Treatment 2

CC220 0.45mg

Cohort A: Treatment 3

CC220 0.60mg

Cohort A: Treatment 4

CC220 0.75mg

Cohort A: Treatment 5

CC220 0.90mg

Cohort A: Treatment 6

CC220 1.0mg

Cohort B: Treatment 1

CC220 0.30mg + DEX

Cohort B: Treatment 2

CC220 0.45mg + DEX

Cohort B: Treatment 3

CC220 0.60mg + DEX

Cohort B: Treatment 4

CC220 0.75mg + DEX

Cohort B: Treatment 5

CC220 0.90mg + DEX

Cohort B: Treatment 6

CC220 1.0mg + DEX

Cohort B: Treatment 7

CC220 1.1mg + DEX

Cohort B: Treatment 8

CC220 1.2mg + DEX

Cohort B: Treatment 9

CC220 1.3.mg + DEX

Cohort B: Treatment 10

CC220 1.6mg + DEX

Cohort D: Treatment 1

CC220 + DEX

Cohort E: Treatment 1

CC220 1.0mg + DARA + DEX

Cohort E: Treatment 2

CC220 1.1mg + DARA + DEX

Cohort E: Treatment 3

CC220 1.2mg + DARA + DEX

Cohort E: Treatment 4

CC220 1.3mg + DARA + DEX

Cohort E: Treatment 5

CC220 1.6mg + DARA + DEX

Cohort F: Treatment 1

CC220 1.0mg + BORT + DEX

Cohort F: Treatment 2

CC220 1.1mg + BORT + DEX

Cohort F: Treatment 3

CC220 1.3mg + BORT + DEX

Cohort F: Treatment 4

CC220 1.6mg + BORT + DEX

Cohort G: Treatment 1

CC220 1.1mg + CFZ + DEX

Cohort G: Treatment 2

CC220 1.3mg + CFZ + DEX

Cohort G: Treatment 3

CC220 1.6mg + CFZ + DEX

Cohort H1

CC220 + DEX

Cohort H2

CC220 + DEX

Cohort I

CC220 + DEX

Cohort J1: Treatment 1

CC220Vd 1.0mg + NE-ASCT

Cohort J1: Treatment 2

CC220Vd 1.6mg + NE-ASCT

Cohort K: Treatment 1

CC220 1.0mg + DARA + DEX

Cohort K: Treatment 2

CC220 1.3mg + DARA + DEX

Cohort K: Treatment 3

CC220 1.6mg + DARA + DEX

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

Analysis denominator · Participants

GroupSource count
Cohort A: Treatment 13
Cohort A: Treatment 23
Cohort A: Treatment 34
Cohort A: Treatment 46
Cohort A: Treatment 56
Cohort A: Treatment 67
Cohort B: Treatment 110
Cohort B: Treatment 23
Cohort B: Treatment 33
Cohort B: Treatment 43
Cohort B: Treatment 513
Cohort B: Treatment 613
Cohort B: Treatment 710
Cohort B: Treatment 88
Cohort B: Treatment 914
Cohort B: Treatment 1013
Cohort D: Treatment 1107
Cohort E: Treatment 13
Cohort E: Treatment 23
Cohort E: Treatment 35
Cohort E: Treatment 413
Cohort E: Treatment 526
Cohort F: Treatment 13
Cohort F: Treatment 27
Cohort F: Treatment 310
Cohort F: Treatment 49
Cohort G: Treatment 14
Cohort G: Treatment 28
Cohort G: Treatment 34
Cohort H10
Cohort H20
Cohort I0
Cohort J1: Treatment 11
Cohort J1: Treatment 217
Cohort K: Treatment 125
Cohort K: Treatment 225
Cohort K: Treatment 325

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Treatment 11Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 20Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 30Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 41Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 50Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 61Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 11Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 21Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 30Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 40Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 50Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 60Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 70Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 80Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 91Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 100Not reportedNot reportedNot reportedNot reported
Cohort D: Treatment 19Not reportedNot reportedNot reportedNot reported
Cohort E: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort E: Treatment 20Not reportedNot reportedNot reportedNot reported
Cohort E: Treatment 30Not reportedNot reportedNot reportedNot reported
Cohort E: Treatment 41Not reportedNot reportedNot reportedNot reported
Cohort E: Treatment 52Not reportedNot reportedNot reportedNot reported
Cohort F: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort F: Treatment 20Not reportedNot reportedNot reportedNot reported
Cohort F: Treatment 31Not reportedNot reportedNot reportedNot reported
Cohort F: Treatment 43Not reportedNot reportedNot reportedNot reported
Cohort G: Treatment 11Not reportedNot reportedNot reportedNot reported
Cohort G: Treatment 20Not reportedNot reportedNot reportedNot reported
Cohort G: Treatment 31Not reportedNot reportedNot reportedNot reported
Cohort J1: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort J1: Treatment 24Not reportedNot reportedNot reportedNot reported
Cohort K: Treatment 12Not reportedNot reportedNot reportedNot reported
Cohort K: Treatment 20Not reportedNot reportedNot reportedNot reported
Cohort K: Treatment 30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
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
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      7
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      13
    12. group Id
      OG011
      value
      13
    units
    Participants
description
An adverse event of special interest (AESI) is one of scientific and medical interest specific to understanding the safety profile of the Investigational Product, CC-220, and may require close monitoring and rapid communication by the Investigator to the Sponsor. An AESI may be serious or nonserious. The rapid reporting of AESIs allows ongoing surveillance of these events in order to characterize and understand their association with the use of this investigational product.
groups
  1. description
    CC220 0.30mg
    id
    OG000
    title
    Cohort A: Treatment 1
  2. description
    CC220 0.45mg
    id
    OG001
    title
    Cohort A: Treatment 2
  3. description
    CC220 0.60mg
    id
    OG002
    title
    Cohort A: Treatment 3
  4. description
    CC220 0.75mg
    id
    OG003
    title
    Cohort A: Treatment 4
  5. description
    CC220 0.90mg
    id
    OG004
    title
    Cohort A: Treatment 5
  6. description
    CC220 1.0mg
    id
    OG005
    title
    Cohort A: Treatment 6
  7. description
    CC220 0.30mg + DEX
    id
    OG006
    title
    Cohort B: Treatment 1
  8. description
    CC220 0.45mg + DEX
    id
    OG007
    title
    Cohort B: Treatment 2
  9. description
    CC220 0.60mg + DEX
    id
    OG008
    title
    Cohort B: Treatment 3
  10. description
    CC220 0.75mg + DEX
    id
    OG009
    title
    Cohort B: Treatment 4
  11. description
    CC220 0.90mg + DEX
    id
    OG010
    title
    Cohort B: Treatment 5
  12. description
    CC220 1.0mg + DEX
    id
    OG011
    title
    Cohort B: Treatment 6
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population with Secondary Primary Malignancies. Cohorts H1, H2 and I did not have SPMs
reporting Status
POSTED
time Frame
Approximately on average of (Cohort A: 16.23 Cohort B: 10.32 Cohort D: 18.68 Cohort E: 15.65 Cohort F: 12.66 Cohort G: 16.03 Cohort H1: 17.22 Cohort H2: 21.07 Cohort I: 17.10 Cohort J: 20.56 Cohort K: 13.56) Months
title
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice