NCT01326871 · OUTCOME

Number of Participants With Adverse Events

A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer · Source last updated 2024-06-25

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: 8 weeks

What was measured

Number of AEs that occur or worsen after the first dose of study treatment

Groups in this outcome

ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine

Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course

ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine

ALT-801 0.06 mg/kg With Gemcitabine

Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course

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
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine	3
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine	49
ALT-801 0.06 mg/kg With Gemcitabine	16

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine	3	Not reported	Not reported	Not reported	Not reported
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine	49	Not reported	Not reported	Not reported	Not reported
ALT-801 0.06 mg/kg With Gemcitabine	16	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
49
group Id
OG002
value
16

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
49
group Id
OG002
value
16
units
Participants

description

Number of AEs that occur or worsen after the first dose of study treatment

groups

description
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
id
OG000
title
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
description
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
id
OG001
title
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
description
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
id
OG002
title
ALT-801 0.06 mg/kg With Gemcitabine

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

8 weeks

title

Number of Participants With Adverse Events

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice