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NCT03340883 · OUTCOME

Safety Profile (Phase 2)

Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM) · Source last updated 2021-04-01

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
28 days

What was measured

BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities

Analysis population: Study was terminated early and Phase 2 was not enrolled. Safety profile was not assessed.

Groups in this outcome

BION-1301 50 mg Q2W

50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.

BION-1301 150 mg Q2W

150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 450 mg Q2W

450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 1350 mg Q2W

1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 2700 mg Q2W

2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 1350 mg QW*8W->Q2W

1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.

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

Analysis denominator · Participants

GroupSource count
BION-1301 50 mg Q2W0
BION-1301 150 mg Q2W0
BION-1301 450 mg Q2W0
BION-1301 1350 mg Q2W0
BION-1301 2700 mg Q2W0
BION-1301 1350 mg QW*8W->Q2W0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
description
BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities
groups
  1. description
    50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
    id
    OG000
    title
    BION-1301 50 mg Q2W
  2. description
    150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    OG001
    title
    BION-1301 150 mg Q2W
  3. description
    450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    OG002
    title
    BION-1301 450 mg Q2W
  4. description
    1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    OG003
    title
    BION-1301 1350 mg Q2W
  5. description
    2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    OG004
    title
    BION-1301 2700 mg Q2W
  6. description
    1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
    id
    OG005
    title
    BION-1301 1350 mg QW*8W->Q2W
population Description
Study was terminated early and Phase 2 was not enrolled. Safety profile was not assessed.
reporting Status
POSTED
time Frame
28 days
title
Safety Profile (Phase 2)
type
PRIMARY

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

Preserved source evidence · Not medical advice