NCT00022633 · ADVERSE EVENTS

Adverse events

S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract · Source last updated 2016-08-11

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: Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.
Other-event reporting threshold: 5%

Elderly Cohort (Age \>= 70 years)

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Paclitaxel + Gemcitabine Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)	5 / 51	50 / 51	Not reported / Not reported

Group identifiers: EG000: Paclitaxel + 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
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Cardiovascular-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Supraventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Flu-like symptoms-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
51
term
Reportable adverse event, NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Respiratory infect w/ neutrop
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Dyspnea

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
29
num At Risk
51
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
10
num At Risk
51
term
PRBC transfusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
4
num At Risk
51
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
6
num At Risk
51
term
Abdominal pain/cramping
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
16
num At Risk
51
term
Constipation/bowel obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
12
num At Risk
51
term
Diarrhea without colostomy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
51
term
Esophagitis/dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
25
num At Risk
51
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
4
num At Risk
51
term
Stomatitis/pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
9
num At Risk
51
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
14
num At Risk
51
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
42
num At Risk
51
term
Fatigue/malaise/lethargy

Complete source fields

description

Elderly Cohort (Age \>= 70 years)

event Groups

description
Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
id
EG000
other Num Affected
50
other Num At Risk
51
serious Num Affected
5
serious Num At Risk
51
title
Paclitaxel + Gemcitabine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
29
num At Risk
51
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
10
num At Risk
51
term
PRBC transfusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
4
num At Risk
51
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
6
num At Risk
51
term
Abdominal pain/cramping
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
16
num At Risk
51
term
Constipation/bowel obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
12
num At Risk
51
term
Diarrhea without colostomy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
51
term
Esophagitis/dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
25
num At Risk
51
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
4
num At Risk
51
term
Stomatitis/pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
9
num At Risk
51
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
14
num At Risk
51
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
42
num At Risk
51
term
Fatigue/malaise/lethargy

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Cardiovascular-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Supraventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Flu-like symptoms-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
51
term
Reportable adverse event, NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Respiratory infect w/ neutrop
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
51
term
Dyspnea

time Frame

Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.

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Preserved source evidence · Not medical advice