NCT00844649 · ADVERSE EVENTS

Adverse events

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas · Source last updated 2019-11-25

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: Day 1 up to 30 days after the last dose (a maximum of 666 days)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest	212 / 421	412 / 421	Not reported / Not reported
Gemcitabine Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)	172 / 402	392 / 402	Not reported / Not reported

Group identifiers: EG000: Albumin-bound Paclitaxel (ABI-007)/Gemcitabine · EG001: 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
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
18
num At Risk
421
group Id
EG001
num Affected
12
num At Risk
402
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
11
num At Risk
421
group Id
EG001
num Affected
10
num At Risk
402
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
11
num At Risk
421
group Id
EG001
num Affected
8
num At Risk
402
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
9
num At Risk
421
group Id
EG001
num Affected
3
num At Risk
402
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
4
num At Risk
421
group Id
EG001
num Affected
5
num At Risk
402
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
4
num At Risk
421
group Id
EG001
num Affected
1
num At Risk
402
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
4
num At Risk
421
group Id
EG001
num Affected
1
num At Risk
402
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
3
num At Risk
421
group Id
EG001
num Affected
2
num At Risk
402
term
Duodenal Obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
2
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
402
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
2
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
402
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
2
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
402
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
2
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
402
term
Upper gastrointestinal haemorrhage

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
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
247
num At Risk
421
group Id
EG001
num Affected
183
num At Risk
402
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
194
num At Risk
421
group Id
EG001
num Affected
123
num At Risk
402
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
160
num At Risk
421
group Id
EG001
num Affected
111
num At Risk
402
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
77
num At Risk
421
group Id
EG001
num Affected
51
num At Risk
402
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
48
num At Risk
421
group Id
EG001
num Affected
34
num At Risk
402
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
42
num At Risk
421
group Id
EG001
num Affected
16
num At Risk
402
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
24
num At Risk
421
group Id
EG001
num Affected
8
num At Risk
402
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
223
num At Risk
421
group Id
EG001
num Affected
189
num At Risk
402
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
182
num At Risk
421
group Id
EG001
num Affected
94
num At Risk
402
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
145
num At Risk
421
group Id
EG001
num Affected
107
num At Risk
402
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
122
num At Risk
421
group Id
EG001
num Affected
111
num At Risk
402
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
92
num At Risk
421
group Id
EG001
num Affected
87
num At Risk
402
term
Abdominal Pain

Complete source fields

event Groups

description
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
id
EG000
other Num Affected
412
other Num At Risk
421
serious Num Affected
212
serious Num At Risk
421
title
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
description
Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
id
EG001
other Num Affected
392
other Num At Risk
402
serious Num Affected
172
serious Num At Risk
402
title
Gemcitabine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
247
num At Risk
421
group Id
EG001
num Affected
183
num At Risk
402
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
194
num At Risk
421
group Id
EG001
num Affected
123
num At Risk
402
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
160
num At Risk
421
group Id
EG001
num Affected
111
num At Risk
402
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
77
num At Risk
421
group Id
EG001
num Affected
51
num At Risk
402
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
48
num At Risk
421
group Id
EG001
num Affected
34
num At Risk
402
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
42
num At Risk
421
group Id
EG001
num Affected
16
num At Risk
402
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
24
num At Risk
421
group Id
EG001
num Affected
8
num At Risk
402
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
223
num At Risk
421
group Id
EG001
num Affected
189
num At Risk
402
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
182
num At Risk
421
group Id
EG001
num Affected
94
num At Risk
402
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
145
num At Risk
421
group Id
EG001
num Affected
107
num At Risk
402
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
122
num At Risk
421
group Id
EG001
num Affected
111
num At Risk
402
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
92
num At Risk
421
group Id
EG001
num Affected
87
num At Risk
402
term
Abdominal Pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
18
num At Risk
421
group Id
EG001
num Affected
12
num At Risk
402
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
11
num At Risk
421
group Id
EG001
num Affected
10
num At Risk
402
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
11
num At Risk
421
group Id
EG001
num Affected
8
num At Risk
402
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
9
num At Risk
421
group Id
EG001
num Affected
3
num At Risk
402
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
4
num At Risk
421
group Id
EG001
num Affected
5
num At Risk
402
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
4
num At Risk
421
group Id
EG001
num Affected
1
num At Risk
402
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
4
num At Risk
421
group Id
EG001
num Affected
1
num At Risk
402
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
3
num At Risk
421
group Id
EG001
num Affected
2
num At Risk
402
term
Duodenal Obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
2
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
402
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
2
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
402
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
2
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
402
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
2
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
402
term
Upper gastrointestinal haemorrhage

time Frame

Day 1 up to 30 days after the last dose (a maximum of 666 days)

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Preserved source evidence · Not medical advice