Skip to content
TriangleGet started
← Full study record

NCT03595657 · OUTCOME

Number of Participants With Adverse Events

A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL) · Source last updated 2024-06-18

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
From enrollment to end of follow-up, a median of 29 months

Groups in this outcome

R/R ENKTL

Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)

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

Analysis denominator · Participants

GroupSource count
R/R ENKTL80

Reported measurements

Treatment-Emergent Adverse Event (TEAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL77Not reportedNot reportedNot reportedNot reported
Treatment-Related Adverse Event (TRAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL63Not reportedNot reportedNot reportedNot reported
Serious Adverse Event (SAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL22Not reportedNot reportedNot reportedNot reported
Related SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL8Not reportedNot reportedNot reportedNot reported
≥G3 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL37Not reportedNot reportedNot reportedNot reported
≥G3 TRAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL15Not reportedNot reportedNot reportedNot reported
Infusion-related Reaction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL4Not reportedNot reportedNot reportedNot reported
TEAE of special interest
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL24Not reportedNot reportedNot reportedNot reported
TEAE of special interest grade 3-5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL2Not reportedNot reportedNot reportedNot reported
TEAE Leading to Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL5Not reportedNot reportedNot reportedNot reported
TEAE Leading to Drug Permanently Discontinued
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL14Not reportedNot reportedNot reportedNot reported
TEAE Leading to Infusion Interruption
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL4Not reportedNot reportedNot reportedNot reported
TEAE Leading to Treatment Cycle Delay
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R/R ENKTL22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        77
    title
    Treatment-Emergent Adverse Event (TEAE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        63
    title
    Treatment-Related Adverse Event (TRAE)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    Serious Adverse Event (SAE)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Related SAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        37
    title
    ≥G3 TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    ≥G3 TRAE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Infusion-related Reaction
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    TEAE of special interest
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    TEAE of special interest grade 3-5
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    TEAE Leading to Death
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    TEAE Leading to Drug Permanently Discontinued
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    TEAE Leading to Infusion Interruption
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    units
    Participants
groups
  1. description
    Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
    id
    OG000
    title
    R/R ENKTL
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From enrollment to end of follow-up, a median of 29 months
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice