Trial Outcomes & Findings for ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years (NCT NCT04532528)
NCT ID: NCT04532528
Last Updated: 2025-05-15
Results Overview
Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
COMPLETED
897 participants
at 12 months
2025-05-15
Participant Flow
A retrospective cohort data analysis was conducted to assess the impact of an advanced educational intervention on the adherence to dabigatran in newly diagnosed atrial fibrillation adult patients under 75 years old in Taiwan.
Only participants that met all inclusion and none of the exclusion criteria were included. Participants were equally randomized in two cohorts: 'standard of care' and 'standard of care with advanced educational intervention'. Out of the 897 screened participants only 873 met the eligibility criteria and were included in the study.
Participant milestones
| Measure |
Standard of Care (SOC) Only
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Overall Study
STARTED
|
441
|
432
|
|
Overall Study
3 Months
|
368
|
366
|
|
Overall Study
6 Months
|
308
|
312
|
|
Overall Study
9 Months
|
286
|
266
|
|
Overall Study
12 Months
|
271
|
246
|
|
Overall Study
COMPLETED
|
269
|
243
|
|
Overall Study
NOT COMPLETED
|
172
|
189
|
Reasons for withdrawal
| Measure |
Standard of Care (SOC) Only
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
17
|
|
Overall Study
Withdrawal of consent
|
16
|
17
|
|
Overall Study
Participant stop Dabigatran during the 12-month study period
|
22
|
24
|
|
Overall Study
Lost to Follow-up
|
69
|
68
|
|
Overall Study
Administrative problems
|
12
|
14
|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Other
|
38
|
46
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care (SOC) Only
n=441 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=432 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
Total
n=873 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 7.70 • n=441 Participants
|
64.7 Years
STANDARD_DEVIATION 7.49 • n=432 Participants
|
65.0 Years
STANDARD_DEVIATION 7.60 • n=873 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=441 Participants
|
167 Participants
n=432 Participants
|
348 Participants
n=873 Participants
|
|
Sex: Female, Male
Male
|
260 Participants
n=441 Participants
|
265 Participants
n=432 Participants
|
525 Participants
n=873 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Race/Ethnicity, Customized
Taiwanese
|
441 Participants
n=441 Participants
|
430 Participants
n=432 Participants
|
871 Participants
n=873 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=441 Participants
|
2 Participants
n=432 Participants
|
2 Participants
n=873 Participants
|
PRIMARY outcome
Timeframe: at 12 monthsPopulation: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had high adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.
Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Outcome measures
| Measure |
Standard of Care (SOC) Only
n=271 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=246 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention
|
199 Participants
|
181 Participants
|
SECONDARY outcome
Timeframe: at 3, 6, and 9 monthsPopulation: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had high adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.
Number of patients with high adherence to dabigatran treatment at 3, 6, and 9 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Outcome measures
| Measure |
Standard of Care (SOC) Only
n=363 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=364 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention
At 3 months
|
224 Participants
|
229 Participants
|
|
Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention
At 6 months
|
199 Participants
|
218 Participants
|
|
Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention
At 9 months
|
204 Participants
|
184 Participants
|
SECONDARY outcome
Timeframe: At 3, 6, 9, and 12 monthsPopulation: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had medium adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.
Number of patients with medium adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A medium adherence was defined as achieving a MMAS-8 score of 6 or 7 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Outcome measures
| Measure |
Standard of Care (SOC) Only
n=363 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=364 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 3 months
|
83 Participants
|
77 Participants
|
|
Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 6 months
|
66 Participants
|
57 Participants
|
|
Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 9 months
|
52 Participants
|
53 Participants
|
|
Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 12 months
|
50 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: At 3, 6, 9, and 12 monthsPopulation: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had low adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.
Number of patients with low adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A low adherence was defined as achieving a MMAS-8 score of 0, 1, 2, 3, 4, or 5 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Outcome measures
| Measure |
Standard of Care (SOC) Only
n=363 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=364 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 3 months
|
56 Participants
|
58 Participants
|
|
Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 6 months
|
35 Participants
|
28 Participants
|
|
Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 9 months
|
28 Participants
|
25 Participants
|
|
Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 12 months
|
22 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: At 3, 6, 9, and 12 monthsPopulation: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis.
Mean Morisky 8-Item Medication Adherence Questionnaire (MMAS-8) score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Outcome measures
| Measure |
Standard of Care (SOC) Only
n=363 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=364 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 3 months
|
7.0 Score on a scale
Standard Deviation 1.65
|
7.0 Score on a scale
Standard Deviation 1.72
|
|
Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 6 months
|
7.2 Score on a scale
Standard Deviation 1.41
|
7.3 Score on a scale
Standard Deviation 1.38
|
|
Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 9 months
|
7.4 Score on a scale
Standard Deviation 1.25
|
7.3 Score on a scale
Standard Deviation 1.27
|
|
Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
At 12 months
|
7.4 Score on a scale
Standard Deviation 1.21
|
7.5 Score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis.
Number of patients who discontinued treatment with dabigatran in patients with and without advanced educational intervention.
Outcome measures
| Measure |
Standard of Care (SOC) Only
n=440 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=431 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention
Yes
|
167 Participants
|
181 Participants
|
|
Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention
No
|
225 Participants
|
213 Participants
|
|
Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention
Not done
|
48 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis.
Number of patients who discontinued treatment with dabigatran and reasons why they discontinued in patients with and without advanced educational intervention.
Outcome measures
| Measure |
Standard of Care (SOC) Only
n=167 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=181 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention
Switched to other treatment
|
60 Participants
|
70 Participants
|
|
Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention
Other
|
107 Participants
|
111 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention and then switched treatment. Arms were mutually exclusive. Only patients with available data were included in this analysis.
Number of patients who switched treatment with dabigatran and reasons why they switched in patients with and without advanced educational intervention
Outcome measures
| Measure |
Standard of Care (SOC) Only
n=60 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=70 Participants
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
Adverse event
|
12 Participants
|
13 Participants
|
|
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
Inconvenience
|
3 Participants
|
3 Participants
|
|
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
Cost
|
1 Participants
|
0 Participants
|
|
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
Treatment failure
|
4 Participants
|
8 Participants
|
|
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
Other reasons
|
40 Participants
|
46 Participants
|
Adverse Events
Standard of Care (SOC) Only
SOC With Advanced Educational Intervention
Serious adverse events
| Measure |
Standard of Care (SOC) Only
n=441 participants at risk
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
|
SOC With Advanced Educational Intervention
n=432 participants at risk
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.23%
1/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
General disorders
Death
|
0.23%
1/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.00%
0/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Infections and infestations
Septic shock
|
0.23%
1/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.00%
0/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.23%
1/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.23%
1/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.23%
1/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Natural killer-cell lymphoblastic lymphoma
|
0.00%
0/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.23%
1/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.23%
1/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.23%
1/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.23%
1/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
1/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.00%
0/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
|
Nervous system disorders
Hemiparesis
|
0.23%
1/441 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
0.00%
0/432 • From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place