NCT01326871 · ADVERSE EVENTS

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	0 / 3	3 / 3	2 / 3
ALT-801 0.06 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	20 / 49	49 / 49	42 / 49
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	8 / 16	16 / 16	16 / 16

Group identifiers: EG000: ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine · EG001: ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine · EG002: ALT-801 0.06 mg/kg With Gemcitabine

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Multiple organ dysfunction syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
3
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Dyspnoea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
36
num At Risk
49
group Id
EG002
num Affected
5
num At Risk
16
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
24
num At Risk
49
group Id
EG002
num Affected
7
num At Risk
16
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
23
num At Risk
49
group Id
EG002
num Affected
5
num At Risk
16
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
15
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
7
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
3
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
39
num At Risk
49
group Id
EG002
num Affected
8
num At Risk
16
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
29
num At Risk
49
group Id
EG002
num Affected
6
num At Risk
16
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
19
num At Risk
49
group Id
EG002
num Affected
5
num At Risk
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
19
num At Risk
49
group Id
EG002
num Affected
4
num At Risk
16
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
7
num At Risk
49
group Id
EG002
num Affected
2
num At Risk
16
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
8
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Stomatitis

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
3
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
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
deaths Num Affected
42
deaths Num At Risk
49
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
EG001
other Num Affected
49
other Num At Risk
49
serious Num Affected
20
serious Num At Risk
49
title
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
deaths Num Affected
16
deaths Num At Risk
16
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
EG002
other Num Affected
16
other Num At Risk
16
serious Num Affected
8
serious Num At Risk
16
title
ALT-801 0.06 mg/kg With Gemcitabine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
36
num At Risk
49
group Id
EG002
num Affected
5
num At Risk
16
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
24
num At Risk
49
group Id
EG002
num Affected
7
num At Risk
16
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
23
num At Risk
49
group Id
EG002
num Affected
5
num At Risk
16
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
15
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
7
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
3
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
39
num At Risk
49
group Id
EG002
num Affected
8
num At Risk
16
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
29
num At Risk
49
group Id
EG002
num Affected
6
num At Risk
16
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
19
num At Risk
49
group Id
EG002
num Affected
5
num At Risk
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
19
num At Risk
49
group Id
EG002
num Affected
4
num At Risk
16
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
7
num At Risk
49
group Id
EG002
num Affected
2
num At Risk
16
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
8
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Multiple organ dysfunction syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
49
group Id
EG002
num Affected
0
num At Risk
16
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
3
num At Risk
49
group Id
EG002
num Affected
1
num At Risk
16
term
Dyspnoea

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