NCT01282463 · OUTCOME

Number of Participants With Adverse Events (AEs)

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

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 41.7 Months

What was measured

A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Analysis population: All randomized participants who received at least one dose of study drug.

Groups in this outcome

Docetaxel

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Docetaxel + Ramucirumab DP

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Docetaxel + Icrucumab

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

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
Docetaxel	45
Docetaxel + Ramucirumab DP	46
Docetaxel + Icrucumab	49

Reported measurements

Any AE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	45	Not reported	Not reported	Not reported	Not reported
Docetaxel + Ramucirumab DP	46	Not reported	Not reported	Not reported	Not reported
Docetaxel + Icrucumab	49	Not reported	Not reported	Not reported	Not reported

Any SAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	19	Not reported	Not reported	Not reported	Not reported
Docetaxel + Ramucirumab DP	25	Not reported	Not reported	Not reported	Not reported
Docetaxel + Icrucumab	22	Not reported	Not reported	Not reported	Not reported

Complete source fields

calculate Pct

false

classes

categories
measurements
group Id
OG000
value
45
group Id
OG001
value
46
group Id
OG002
value
49
title
Any AE
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
25
group Id
OG002
value
22
title
Any SAE

denoms

counts
group Id
OG000
value
45
group Id
OG001
value
46
group Id
OG002
value
49
units
Participants

description

A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

groups

description
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
id
OG000
title
Docetaxel
description
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
id
OG001
title
Docetaxel + Ramucirumab DP
description
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
id
OG002
title
Docetaxel + Icrucumab

param Type

COUNT_OF_PARTICIPANTS

population Description

All randomized participants who received at least one dose of study drug.

reporting Status

POSTED

time Frame

Up To 41.7 Months

title

Number of Participants With Adverse Events (AEs)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice