Trial Outcomes & Findings for Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa (NCT NCT02022020)
NCT ID: NCT02022020
Last Updated: 2017-01-31
Results Overview
Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release. Emergency Department/Room (ED/ER). Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as: * Ongoing, if symptoms of bleeding not completely resolved at time of discharge; * Deceased in case of death; * Resolved otherwise.
Recruitment status
COMPLETED
Target enrollment
220 participants
Primary outcome timeframe
From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.
Results posted on
2017-01-31
Participant Flow
This was an observational chart abstraction study.
297 subjects were captured in the initial screening. 74 patients were deemed ineligible. A total of 3 patients were withdrawn after being included in the final study cohort following verification of ineligibility leaving 220 subjects eligible for study entry who were enrolled and included in the final study.
Participant milestones
| Measure |
Dabigatran (Pradax® in Canada; Pradaxa® in the United States)
Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
|
|---|---|
|
Overall Study
STARTED
|
220
|
|
Overall Study
COMPLETED
|
220
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa
Baseline characteristics by cohort
| Measure |
Dabigatran (Pradax® in Canada; Pradaxa® in the United States)
n=220 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
|
|---|---|
|
Age, Continuous
|
76.1 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Gender
Female
|
108 Participants
n=5 Participants
|
|
Gender
Male
|
112 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.Population: Patients who received treatment at two countries (United States and Canada).
Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release. Emergency Department/Room (ED/ER). Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as: * Ongoing, if symptoms of bleeding not completely resolved at time of discharge; * Deceased in case of death; * Resolved otherwise.
Outcome measures
| Measure |
Dabigatran (Pradax® in Canada; Pradaxa® in the United States)
n=220 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
|
|---|---|
|
Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge
Ongoing
|
19.1 Percentage of participants
|
|
Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge
Resolved
|
76.8 Percentage of participants
|
|
Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge
Deceased
|
4.1 Percentage of participants
|
PRIMARY outcome
Timeframe: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.Population: Patients who received treatment at two countries (United States and Canada).
Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.
Outcome measures
| Measure |
Dabigatran (Pradax® in Canada; Pradaxa® in the United States)
n=220 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
|
|---|---|
|
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
Any general intervention
|
77.3 Percentage of participants
|
|
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
Medications
|
13.6 Percentage of participants
|
|
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
Surgery
|
6.8 Percentage of participants
|
|
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
Therapeutic procedures
|
9.5 Percentage of participants
|
|
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
Transfusion/infusion
|
36.8 Percentage of participants
|
|
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
Discontinuation of dabigatran
|
71.4 Percentage of participants
|
|
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
No interventions
|
22.7 Percentage of participants
|
PRIMARY outcome
Timeframe: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.Population: Patients who received treatment at two countries (United States and Canada).
Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.
Outcome measures
| Measure |
Dabigatran (Pradax® in Canada; Pradaxa® in the United States)
n=220 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
|
|---|---|
|
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
Both GI and GU
|
0.2 Percentage of participants
|
|
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
GI Bleed
|
73.2 Percentage of participants
|
|
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
Upper GI Bleed
|
15.5 Percentage of participants
|
|
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
Lower GI Bleed
|
45.9 Percentage of participants
|
|
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
GI Bleed - Location Unknown
|
12.7 Percentage of participants
|
|
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
GU Bleed
|
28.6 Percentage of participants
|
Adverse Events
Dabigatran (Pradax® in Canada; Pradaxa® in the United States
Serious events: 184 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dabigatran (Pradax® in Canada; Pradaxa® in the United States
n=220 participants at risk
Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
|
|---|---|
|
Renal and urinary disorders
Haematuria
|
14.5%
32/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
23.6%
52/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
14.5%
32/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Blood and lymphatic system disorders
Anaemia
|
10.5%
23/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
10.0%
22/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
10.0%
22/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Haematochezia
|
6.4%
14/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
6/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Melaena
|
5.0%
11/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
4/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
General disorders
Chest pain
|
1.4%
3/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Dizziness
|
1.4%
3/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
5/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
8/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Vascular disorders
Hypotension
|
3.2%
7/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Nausea
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Urinary tract infection
|
1.8%
4/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Cardiac disorders
Cardiac failure congestive
|
3.2%
7/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.8%
4/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Anal haemorrhage
|
2.3%
5/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Haematemesis
|
2.7%
6/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Sepsis
|
2.7%
6/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
General disorders
Fatigue
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
International normalised ratio increased
|
1.4%
3/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
General disorders
Pyrexia
|
1.4%
3/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
General disorders
Asthenia
|
1.4%
3/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
Haemoglobin decreased
|
1.8%
4/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Headache
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Dysuria
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Injury, poisoning and procedural complications
Fall
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Syncope
|
1.4%
3/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Cardiac disorders
Tachycardia
|
1.4%
3/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
1.4%
3/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Clostridium difficile infection
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Dysarthria
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Endocarditis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Gastritis
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
Occult blood positive
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Vascular disorders
Orthostatic hypotension
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Pneumonia
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.91%
2/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Renal failure
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Ataxia
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Cardiac disorders
Atrial thrombosis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Bladder obstruction
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
Blood creatine increased
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
Blood urea increased
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Calculus bladder
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Cardiac disorders
Cardiac failure
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
General disorders
Catheter site haemorrhage
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Cellulitis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Diverticulitis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Embolic stroke
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
General physical condition abnormal
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
Haematocrit decreased
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Hemiparesis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Cardiac disorders
Hypertensive heart disease
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Hypoaesthesia
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
International normalised ratio
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
International normalised ratio abnormal
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Investigations
International normalised ratio normal
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Localised infection
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Psychiatric disorders
Mental status changes
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Vascular disorders
Microscopic polyangiitis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Cardiac disorders
Palpitations
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Nervous system disorders
Presyncope
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Renal atrophy
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Renal and urinary disorders
Urinary retention
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Infections and infestations
Urosepsis
|
0.45%
1/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
Other adverse events
| Measure |
Dabigatran (Pradax® in Canada; Pradaxa® in the United States
n=220 participants at risk
Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
|
|---|---|
|
Renal and urinary disorders
Haematuria
|
19.1%
42/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
8.6%
19/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
11.8%
26/220 • From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
|
Additional Information
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