NCT01869725 · ADVERSE EVENTS

Adverse events

Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT · Source last updated 2021-09-22

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: Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Diagnostic (Gallium Ga 68-edotreotide PET/CT) Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan	0 / 68	11 / 68	1 / 68

Group identifiers: EG000: Diagnostic (Gallium Ga 68-edotreotide PET/CT)

Serious adverse events

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

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
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
68
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
cramping
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Gastrointestinal disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
4
num At Risk
68
num Events
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
chills
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
General disorders and administration site conditions - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
68
num Events
2
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
3
num At Risk
68
num Events
3
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
joint stiffness
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Musculoskeletal and connective tissue disorder - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
68
num Events
2
term
Flushing
assessment Type
SYSTEMATIC_ASSESSMENT
notes
skin mottling
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Vascular disorders - Other, specify

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
68
description
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
id
EG000
other Num Affected
11
other Num At Risk
68
serious Num Affected
0
serious Num At Risk
68
title
Diagnostic (Gallium Ga 68-edotreotide PET/CT)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
68
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
cramping
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Gastrointestinal disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
4
num At Risk
68
num Events
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
chills
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
General disorders and administration site conditions - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
68
num Events
2
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
3
num At Risk
68
num Events
3
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
joint stiffness
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Musculoskeletal and connective tissue disorder - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
68
num Events
2
term
Flushing
assessment Type
SYSTEMATIC_ASSESSMENT
notes
skin mottling
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Vascular disorders - Other, specify

time Frame

Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2

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

Preserved source evidence · Not medical advice