Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02661022 · OUTCOME

Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug

SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2024-04-17

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
Up to 12 Months

What was measured

To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (MM)

Groups in this outcome

SL-401 7 µg/kg/Day

SL-401 7 µg/kg/day in combination with pomalidomide/dexamethasone (pom/dex) SL-401 7 µg/kg/day: SL-401 7 µg/kg/day in combination with pomalidomide/dexamethasone (pom/dex)

SL-401 9 µg/kg/Day

SL-401 9 µg/kg/day in combination with pomalidomide/dexamethasone (pom/dex) SL-401 9 µg/kg/day: SL-401 9 µg/kg/day in combination with pomalidomide/dexamethasone (pom/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
SL-401 7 µg/kg/Day7
SL-401 9 µg/kg/Day2

Reported measurements

At Least 1 TEAE Leading to Discontinuation of Study Drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
Capillary leak syndrome
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
Metastatic malignant melanoma
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
Pancreatitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    At Least 1 TEAE Leading to Discontinuation of Study Drug
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Capillary leak syndrome
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Metastatic malignant melanoma
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Pancreatitis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Thrombocytopenia
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      2
    units
    Participants
description
To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (MM)
groups
  1. description
    SL-401 7 µg/kg/day in combination with pomalidomide/dexamethasone (pom/dex) SL-401 7 µg/kg/day: SL-401 7 µg/kg/day in combination with pomalidomide/dexamethasone (pom/dex)
    id
    OG000
    title
    SL-401 7 µg/kg/Day
  2. description
    SL-401 9 µg/kg/day in combination with pomalidomide/dexamethasone (pom/dex) SL-401 9 µg/kg/day: SL-401 9 µg/kg/day in combination with pomalidomide/dexamethasone (pom/dex)
    id
    OG001
    title
    SL-401 9 µg/kg/Day
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 12 Months
title
Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice