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NCT00719901 · OUTCOME

Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)

Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2015-01-12

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
From baseline to up to 3 years

What was measured

Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either "unrelated or unlikely to be related" to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment.

Analysis population: No participants proceeded to Phase II for evaluation.

Groups in this outcome

Treatment (Enzyme Inhibitor Therapy)

Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treatment (Enzyme Inhibitor Therapy)0

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
    units
    Participants
description
Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either "unrelated or unlikely to be related" to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment.
groups
  1. description
    Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Enzyme Inhibitor Therapy)
population Description
No participants proceeded to Phase II for evaluation.
reporting Status
POSTED
time Frame
From baseline to up to 3 years
title
Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)
type
SECONDARY

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

Preserved source evidence · Not medical advice