NCT03926143 · OUTCOME

Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs

A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies · Source last updated 2023-08-04

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: Approximately 3 years (from first study treatment until safety follow-up)

What was measured

Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.

Groups in this outcome

Anetumab Ravtansine

Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.

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

Analysis denominator · Participants

Group	Source count
Anetumab Ravtansine	9

Reported measurements

Any TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Anetumab Ravtansine	9	Not reported	Not reported	Not reported	Not reported

Serious TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Anetumab Ravtansine	2	Not reported	Not reported	Not reported	Not reported

Any study drug-related TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Anetumab Ravtansine	8	Not reported	Not reported	Not reported	Not reported

Any study drug-related Serious TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Anetumab Ravtansine	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
9
title
Any TEAE
categories
measurements
group Id
OG000
value
2
title
Serious TEAE
categories
measurements
group Id
OG000
value
8
title
Any study drug-related TEAE
categories
measurements
group Id
OG000
value
0
title
Any study drug-related Serious TEAE

denoms

counts
group Id
OG000
value
9
units
Participants

description

groups

description
Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
id
OG000
title
Anetumab Ravtansine

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Approximately 3 years (from first study treatment until safety follow-up)

title

Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice