Trial Outcomes & Findings for Vyndaqel Capsules Special Investigation (ATTR-CM) (NCT NCT04108091)
NCT ID: NCT04108091
Last Updated: 2026-05-18
Results Overview
An ADR was any untoward medical occurrence attributed to Vyndaqel capsules 20mg or Vynmac capsules 61mg in a participant who received this drug. A serious ADR was ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to Vyndaqel capsules 20mg or Vynmac capsules 61mg was assessed without distinction.
Recruitment status
COMPLETED
Target enrollment
1214 participants
Primary outcome timeframe
30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
Results posted on
2026-05-18
Participant Flow
Participant milestones
| Measure |
Vyndaqel Capsules 20mg (Tafamidis Meglumine) and Vynmac Capsules 61mg(Tafamidis)
Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of adverse drug reaction \[ADR\]), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg.
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|---|---|
|
Overall Study
STARTED
|
1214
|
|
Overall Study
Included in Safety Analysis Set
|
873
|
|
Overall Study
COMPLETED
|
873
|
|
Overall Study
NOT COMPLETED
|
341
|
Reasons for withdrawal
| Measure |
Vyndaqel Capsules 20mg (Tafamidis Meglumine) and Vynmac Capsules 61mg(Tafamidis)
Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of adverse drug reaction \[ADR\]), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Data consolidated for re-registration by hospital transfer
|
153
|
|
Overall Study
No informed consent for publication of study results
|
180
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
No administration information
|
1
|
|
Overall Study
No adverse event information (No revisits)
|
2
|
Baseline Characteristics
A total of 1,214 participants were enrolled, and case report forms were obtained from 1,211. After consolidating 153 transfer cases and excluding 185 participants with protocol violations, no consent for publication, or no adverse event or administration information, 873 participants were included in the safety analysis set.
Baseline characteristics by cohort
| Measure |
Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis)
n=873 Participants
Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg.
|
|---|---|
|
Age, Customized
<15 years
|
0 Participants
n=873 Participants • A total of 1,214 participants were enrolled, and case report forms were obtained from 1,211. After consolidating 153 transfer cases and excluding 185 participants with protocol violations, no consent for publication, or no adverse event or administration information, 873 participants were included in the safety analysis set.
|
|
Age, Customized
≥15 and <65 years
|
36 Participants
n=873 Participants • A total of 1,214 participants were enrolled, and case report forms were obtained from 1,211. After consolidating 153 transfer cases and excluding 185 participants with protocol violations, no consent for publication, or no adverse event or administration information, 873 participants were included in the safety analysis set.
|
|
Age, Customized
≥65 years
|
837 Participants
n=873 Participants • A total of 1,214 participants were enrolled, and case report forms were obtained from 1,211. After consolidating 153 transfer cases and excluding 185 participants with protocol violations, no consent for publication, or no adverse event or administration information, 873 participants were included in the safety analysis set.
|
|
Sex: Female, Male
Female
|
95 Participants
n=873 Participants • A total of 1,214 participants were enrolled, and case report forms were obtained from 1,211. After consolidating 153 transfer cases and excluding 185 participants with protocol violations, no consent for publication, or no adverse event or administration information, 873 participants were included in the safety analysis set.
|
|
Sex: Female, Male
Male
|
778 Participants
n=873 Participants • A total of 1,214 participants were enrolled, and case report forms were obtained from 1,211. After consolidating 153 transfer cases and excluding 185 participants with protocol violations, no consent for publication, or no adverse event or administration information, 873 participants were included in the safety analysis set.
|
PRIMARY outcome
Timeframe: 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Vyndaqel capsules 20mg or Vynmac capsules 61mg at least once. Participants with protocol violation, or lacking informed consent for publication of study results, adverse event information (no revisits), or administration information were excluded.
An ADR was any untoward medical occurrence attributed to Vyndaqel capsules 20mg or Vynmac capsules 61mg in a participant who received this drug. A serious ADR was ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to Vyndaqel capsules 20mg or Vynmac capsules 61mg was assessed without distinction.
Outcome measures
| Measure |
Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis)
n=873 Participants
Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg.
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|---|---|
|
Number of Participants With Adverse Drug Reactions
Serious ADR
|
7 Participants
|
|
Number of Participants With Adverse Drug Reactions
ADR
|
45 Participants
|
SECONDARY outcome
Timeframe: 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.Population: The efficacy analysis set (EAS) comprised subjects from the SAS, excluding those who were unable to evaluate effectiveness
The proportion of participants who died from any cause and from cardiovascular-related causes during the observation period was assessed.
Outcome measures
| Measure |
Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis)
n=873 Participants
Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg.
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|---|---|
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Percentage of Participants Who Died
Death rate of any cause
|
3.6 percentage of participants
|
|
Percentage of Participants Who Died
Death rate related to cardiovascular events
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.Population: The efficacy analysis set (EAS) comprised subjects from the SAS, excluding those who were unable to evaluate effectiveness.
Changes in NYHA functional classification at Month 30 compared with baseline were summarized using cross-tabulation and expressed as percentages, with the number of participants in each NYHA class at baseline as the denominator. The NYHA class ranges from Class 1 to 4, with lower class numbers indicating better functional status; Class 1 indicates no limitation of physical activity, whereas Class 4 indicates symptoms at rest.
Outcome measures
| Measure |
Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis)
n=873 Participants
Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg.
|
|---|---|
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NYHA Classification Changes
From baseline Class 1 to Month 30 Class 1
|
25.0 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 1 to Month 30 Class 2
|
23.8 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 1 to Month 30 Class 3
|
3.8 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 1 to Month 30 Class 4
|
1.3 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 1 to not assessed at Month 30
|
46.3 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 2 to Month 30 Class 1
|
5.0 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 2 to Month 30 Class 2
|
48.5 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 2 to Month 30 Class 3
|
8.5 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 2 to Month 30 Class 4
|
0.7 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 2 to not assessed at Month 30
|
37.3 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 3 to Month 30 Class 1
|
1.8 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 3 to Month 30 Class 2
|
19.4 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 3 to Month 30 Class 3
|
19.4 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 3 to Month 30 Class 4
|
2.2 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 3 to not assessed at Month 30
|
57.3 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 4 to Month 30 Class 1
|
0.0 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 4 to Month 30 Class 2
|
66.7 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 4 to Month 30 Class 3
|
0.0 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 4 to Month 30 Class 4
|
0.0 Percentage of Participants
|
|
NYHA Classification Changes
From baseline Class 4 to not assessed at Month 30
|
33.3 Percentage of Participants
|
Adverse Events
Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis)
Serious events: 202 serious events
Other events: 101 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis)
n=873 participants at risk
Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg.
|
|---|---|
|
Infections and infestations
COVID-19
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Campylobacter infection
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Muscle abscess
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Aspiration pneumonia
|
0.57%
5/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Osteomyelitis
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Postoperative wound infection
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Orchitis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Appendicitis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Sepsis
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Septic shock
|
0.57%
5/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia
|
0.57%
5/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Peritonitis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Psychiatric disorders
Delirium
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Epilepsy
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Altered state of consciousness
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Hepatic coma
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Dysarthria
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Syncope
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Cerebellar infarction
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Positional vertigo
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Cerebral infarction
|
1.0%
9/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Vertigo
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Eye disorders
Retinal artery occlusion
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Eye disorders
Glaucoma
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Ear and labyrinth disorders
Benign paroxysmal positional vertigo
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
14/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Complete atrioventricular block
|
2.2%
19/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Acute cardiac failure
|
1.1%
10/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Bradycardia
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.80%
7/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure
|
6.1%
53/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Atrial thrombosis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
16/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Atrial flutter
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Atrial tachycardia
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.46%
4/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Sick sinus syndrome
|
1.5%
13/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Arrhythmia
|
0.46%
4/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Atrioventricular block
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure chronic
|
2.2%
19/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Vascular disorders
Jugular vein distension
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Vascular disorders
Hypotension
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Spontaneous pneumothorax
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Haemorrhagic gastric ulcer
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Appendiceal disorder
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Exfoliative dermatitis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Hypokinesia
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Face oedema
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Death
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Ulcer
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Sudden death
|
0.23%
2/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Oedema
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Oedema peripheral
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Drug ineffective
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Traumatic subarachnoid haemorrhage
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.46%
4/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Epidural haematoma
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Femoral fracture
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
3/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.11%
1/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
Other adverse events
| Measure |
Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis)
n=873 participants at risk
Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.57%
5/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
11/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Psychiatric disorders
Insomnia
|
1.1%
10/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
10/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
27/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Atrial tachycardia
|
0.57%
5/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.69%
6/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.69%
6/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
11/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
12/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.92%
8/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.69%
6/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.69%
6/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Fatigue
|
0.57%
5/873 • 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER