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NCT02099539 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events

QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

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
24 weeks

What was measured

For phase I - Number of Participants with Treatment Emergent Adverse Events that occur or worsen after the first dose of study treatment.

Analysis population: Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects

Groups in this outcome

Cohort 1: N-803 - IV 1 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Cohort 2: N-803 - IV 3 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Cohort 3: N-803 - IV 6 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Cohort 4: N-803 - IV 10 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Cohort 5: N-803 - SQ 10 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Cohort 6: N-803 - SQ 15 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

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 1: N-803 - IV 1 ug/kg3
Cohort 2: N-803 - IV 3 ug/kg3
Cohort 3: N-803 - IV 6 ug/kg3
Cohort 4: N-803 - IV 10 ug/kg3
Cohort 5: N-803 - SQ 10 ug/kg4
Cohort 6: N-803 - SQ 15 ug/kg3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: N-803 - IV 1 ug/kg3Not reportedNot reportedNot reportedNot reported
Cohort 2: N-803 - IV 3 ug/kg3Not reportedNot reportedNot reportedNot reported
Cohort 3: N-803 - IV 6 ug/kg3Not reportedNot reportedNot reportedNot reported
Cohort 4: N-803 - IV 10 ug/kg3Not reportedNot reportedNot reportedNot reported
Cohort 5: N-803 - SQ 10 ug/kg4Not reportedNot reportedNot reportedNot reported
Cohort 6: N-803 - SQ 15 ug/kg3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      3
    units
    Participants
description
For phase I - Number of Participants with Treatment Emergent Adverse Events that occur or worsen after the first dose of study treatment.
groups
  1. description
    N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
    id
    OG000
    title
    Cohort 1: N-803 - IV 1 ug/kg
  2. description
    N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
    id
    OG001
    title
    Cohort 2: N-803 - IV 3 ug/kg
  3. description
    N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
    id
    OG002
    title
    Cohort 3: N-803 - IV 6 ug/kg
  4. description
    N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
    id
    OG003
    title
    Cohort 4: N-803 - IV 10 ug/kg
  5. description
    N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
    id
    OG004
    title
    Cohort 5: N-803 - SQ 10 ug/kg
  6. description
    N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
    id
    OG005
    title
    Cohort 6: N-803 - SQ 15 ug/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects
reporting Status
POSTED
time Frame
24 weeks
title
Number of Participants With Treatment Emergent Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice