NCT01273597 · ADVERSE EVENTS

Adverse events

Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands · Source last updated 2013-01-18

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: Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
End-stage Kidney Disease With Secondary Hyperparathyroidism Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)	9 / 60	16 / 60	Not reported / Not reported

Group identifiers: EG000: End-stage Kidney Disease With Secondary Hyperparathyroidism

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Duodenal ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Gastric ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Spinal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Abscess limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Arthritis bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Gangrene

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
Investigations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
5
num At Risk
60
term
Calcium phosphate product increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Hypercalcaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
4
num At Risk
60
term
Hyperphoshataemia

Complete source fields

event Groups

description
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
id
EG000
other Num Affected
16
other Num At Risk
60
serious Num Affected
9
serious Num At Risk
60
title
End-stage Kidney Disease With Secondary Hyperparathyroidism

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
5
num At Risk
60
term
Calcium phosphate product increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Hypercalcaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
4
num At Risk
60
term
Hyperphoshataemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Duodenal ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Gastric ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Spinal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Abscess limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Arthritis bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Gangrene

time Frame

Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.

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Preserved source evidence · Not medical advice