NCT00001277 · ADVERSE EVENTS

Adverse events

Studies of Elevated Parathyroid Activity · Source last updated 2022-06-07

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: 3 months
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Primary Hyperparathyroidism - Incomplete Data Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system	0 / 634	0 / 634	0 / 634
Primary Hyperparathyroidism Patients with confirmed or suspected primary hyperparathyroidism or complications	0 / 900	0 / 900	0 / 900
DOTATATE and F-DOPA Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA 68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors. 18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.	0 / 19	1 / 19	0 / 19

Group identifiers: EG000: Primary Hyperparathyroidism - Incomplete Data · EG001: Primary Hyperparathyroidism · EG002: DOTATATE and F-DOPA

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num At Risk
634
group Id
EG001
num Affected
0
num At Risk
900
group Id
EG002
num Affected
1
num At Risk
19
num Events
1
term
Abdominal pain

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
634
description
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
id
EG000
other Num Affected
0
other Num At Risk
634
serious Num Affected
0
serious Num At Risk
634
title
Primary Hyperparathyroidism - Incomplete Data
deaths Num Affected
0
deaths Num At Risk
900
description
Patients with confirmed or suspected primary hyperparathyroidism or complications
id
EG001
other Num Affected
0
other Num At Risk
900
serious Num Affected
0
serious Num At Risk
900
title
Primary Hyperparathyroidism
deaths Num Affected
0
deaths Num At Risk
19
description
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA 68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors. 18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
id
EG002
other Num Affected
1
other Num At Risk
19
serious Num Affected
0
serious Num At Risk
19
title
DOTATATE and F-DOPA

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num At Risk
634
group Id
EG001
num Affected
0
num At Risk
900
group Id
EG002
num Affected
1
num At Risk
19
num Events
1
term
Abdominal pain

time Frame

3 months

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

Preserved source evidence · Not medical advice