Trial Outcomes & Findings for All-Case Surveillance of Prizbind® (NCT NCT02946931)
NCT ID: NCT02946931
Last Updated: 2022-09-09
Results Overview
Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported.
Recruitment status
COMPLETED
Target enrollment
1402 participants
Primary outcome timeframe
From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Results posted on
2022-09-09
Participant Flow
This post marketing surveillance (PMS) was a non-interventional study based on new data collection to gather data on safety and effectiveness of the Prizbind® for Intravenous Solution under Japanese clinical condition. All patients were administered Prizbind® for Intravenous Solution after the approval at the sites contracted with the sponsor were to be registered.
All patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators were enrolled. Any screening was not conducted.
Participant milestones
| Measure |
Prizbind® for Intravenous Solution
Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
|
|---|---|
|
Overall Study
STARTED
|
1402
|
|
Overall Study
Case Report Forms (CRFs) Collected
|
814
|
|
Overall Study
CRFs Valid
|
813
|
|
Overall Study
COMPLETED
|
571
|
|
Overall Study
NOT COMPLETED
|
831
|
Reasons for withdrawal
| Measure |
Prizbind® for Intravenous Solution
Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
|
|---|---|
|
Overall Study
Did not require collection of CRFs
|
588
|
|
Overall Study
Other than listed
|
37
|
|
Overall Study
Discharge from hospital
|
118
|
|
Overall Study
Adverse Event
|
81
|
|
Overall Study
CRFs not valid
|
1
|
|
Overall Study
CRFs with missing information on the date of termination of PMS
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prizbind® for Intravenous Solution
n=813 Participants
Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
|
|---|---|
|
Age, Continuous
|
76.7 Years
STANDARD_DEVIATION 9.6 • n=813 Participants
|
|
Sex: Female, Male
Female
|
267 Participants
n=813 Participants
|
|
Sex: Female, Male
Male
|
546 Participants
n=813 Participants
|
PRIMARY outcome
Timeframe: From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.Population: Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported.
Outcome measures
| Measure |
Prizbind® for Intravenous Solution
n=813 Participants
Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
|
|---|---|
|
Number of Patients With Adverse Drug Reactions (ADRs)
|
30 Participants
|
SECONDARY outcome
Timeframe: From the end of the first infusion up to 4 hours after the last infusion on Day 1.Population: Patients of the effectiveness set (all patients with Prizbind® in the safety set who have at least one available effectiveness data) whose activated partial thromboplastin time (aPTT) value at baseline exceeded the upper limit of normal (ULN).
Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100.
Outcome measures
| Measure |
Prizbind® for Intravenous Solution
n=103 Participants
Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
|
|---|---|
|
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
|
100.0 percentage
Interval 82.5 to 100.0
|
SECONDARY outcome
Timeframe: From the end of the first infusion up to 4 hours after the last infusion on Day 1.Population: Patients of the effectiveness set (all patients with Prizbind® in the safety set who have at least one available effectiveness data) whose activated partial thromboplastin time (aPTT) value at baseline exceeded the upper limit of normal (ULN).
Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100. Maximum Reversal was categorized in the following 4 categories: 100% 80% \<= and \< 100% 50% \<= and \< 80% \< 50%
Outcome measures
| Measure |
Prizbind® for Intravenous Solution
n=103 Participants
Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
|
|---|---|
|
Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
100 %
|
65 Participants
|
|
Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
80<= and <100 %
|
16 Participants
|
|
Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
50<= and <80 %
|
9 Participants
|
|
Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
<50 %
|
13 Participants
|
Adverse Events
Prizbind® for Intravenous Solution
Serious events: 192 serious events
Other events: 0 other events
Deaths: 103 deaths
Serious adverse events
| Measure |
Prizbind® for Intravenous Solution
n=813 participants at risk
Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
|
|---|---|
|
Infections and infestations
Peritonitis
|
0.49%
4/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Pneumonia
|
0.49%
4/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Gangrene
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Mediastinitis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Meningitis bacterial
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Pyelonephritis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Pyelonephritis acute
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Sepsis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Septic shock
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Systemic candida
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Urinary tract infection
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Pneumonia bacterial
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Infectious pleural effusion
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.37%
3/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.37%
3/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Psychiatric disorders
Delirium
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Psychiatric disorders
Restlessness
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Cerebral infarction
|
2.0%
16/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.2%
10/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Brain oedema
|
0.74%
6/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Seizure
|
0.62%
5/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Embolic stroke
|
0.49%
4/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Epilepsy
|
0.62%
5/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.37%
3/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Hydrocephalus
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Facial paralysis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Hemiplegia
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Spinal cord haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Vascular parkinsonism
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Eye disorders
Eye haematoma
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Cardiac failure
|
0.74%
6/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Arrhythmia
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Cardiac arrest
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Cardiac tamponade
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Myocardial infarction
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Pericardial effusion
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Tachycardia
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Ventricle rupture
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Cardiac perforation
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Shock haemorrhagic
|
0.86%
7/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Haemorrhage
|
0.62%
5/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Arterial occlusive disease
|
0.37%
3/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Aortic dissection
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Circulatory collapse
|
0.37%
3/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Hypotension
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Shock
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Arteriovenous fistula
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Haemorrhagic infarction
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Hypertension
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Coeliac artery occlusion
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.37%
3/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.37%
3/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.49%
4/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.62%
5/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Hepatobiliary disorders
Hepatitis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.49%
4/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Renal and urinary disorders
Renal failure
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Renal and urinary disorders
Urinary retention
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Renal and urinary disorders
Renal impairment
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.62%
5/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
General disorders
Death
|
0.37%
3/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
General disorders
Oedema
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Investigations
Blood pressure decreased
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.3%
19/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.49%
4/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.49%
4/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Infections and infestations
Pneumonia aspiration
|
2.5%
20/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Aneurysm ruptured
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Vascular disorders
Microscopic polyangiitis
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Melaena
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.25%
2/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Constipation
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Intussusception
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.12%
1/813 • From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER