Trial Outcomes & Findings for PMS of Trazenta on the Long-term Use as Add-on Therapy (NCT NCT01904383)
NCT ID: NCT01904383
Last Updated: 2019-10-02
Results Overview
Percentage of participants with drug related adverse events.
Recruitment status
COMPLETED
Target enrollment
4057 participants
Primary outcome timeframe
From first drug administration until last drug administration, up to approximately 156 weeks.
Results posted on
2019-10-02
Participant Flow
An observational, non-randomised, non-interventional study (NIS) in participants diagnosed with type 2 diabetes mellitus (T2DM) who were treated as add-on therapy were included in the surveillance based on newly collected data under routine medical practice. Acronym used: Case report form (CRF)
This non-randomized, post marketing surveillance (PMS) was a prospective study using a continuous investigation system. No specific criteria (e.g., demographics, baseline characteristics, concomitant drugs in use) were defined for participant enrolment. Participants were enrolled from July 2013 to September 2015.
Participant milestones
| Measure |
Trazenta®
Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
|
|---|---|
|
Overall Study
STARTED
|
4057
|
|
Overall Study
Treated
|
3940
|
|
Overall Study
COMPLETED
|
2283
|
|
Overall Study
NOT COMPLETED
|
1774
|
Reasons for withdrawal
| Measure |
Trazenta®
Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
|
|---|---|
|
Overall Study
CRF not collected
|
117
|
|
Overall Study
Reason not listed
|
147
|
|
Overall Study
Lost to Follow-up
|
674
|
|
Overall Study
Lack of Efficacy
|
370
|
|
Overall Study
Improvement
|
141
|
|
Overall Study
Adverse Event
|
271
|
|
Overall Study
No patient visit after entry
|
54
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trazenta®
n=3372 Participants
Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
|
|---|---|
|
Age, Continuous
|
66.5 Years
STANDARD_DEVIATION 12.4 • n=3372 Participants
|
|
Sex: Female, Male
Female
|
1308 Participants
n=3372 Participants
|
|
Sex: Female, Male
Male
|
2064 Participants
n=3372 Participants
|
PRIMARY outcome
Timeframe: From first drug administration until last drug administration, up to approximately 156 weeks.Population: Safety set: This patient set included all patients who were dispensed Trazenta® Tablets as add-on therapy, and had at least 1 observation after treatment. The patients treated with Trazenta® Tablets as monotherapy were not included.
Percentage of participants with drug related adverse events.
Outcome measures
| Measure |
Trazenta®
n=3372 Participants
Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
|
|---|---|
|
Percentage of Participants With Drug Related Adverse Events
|
11.39 Percentage (%) of participants
|
SECONDARY outcome
Timeframe: Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks.Population: Efficacy set: This patient set included all patients with Trazenta® Tablets in the safety set who had a baseline and at least one available on-treatment HbA1c value and had type 2 diabetes mellitus.
The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c).
Outcome measures
| Measure |
Trazenta®
n=3029 Participants
Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
|
|---|---|
|
The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c)
|
-0.49 Percentage (%)
Standard Deviation 1.33
|
Adverse Events
Trazenta®
Serious events: 304 serious events
Other events: 184 other events
Deaths: 74 deaths
Serious adverse events
| Measure |
Trazenta®
n=3372 participants at risk
Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
|
|---|---|
|
Metabolism and nutrition disorders
Marasmus
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.44%
15/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Pneumonia
|
0.18%
6/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Influenza
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Lung infection
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Peritonitis
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Sepsis
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Device related infection
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Gangrene
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Hepatitis B
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Infection
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Liver abscess
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Septic shock
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Sinusitis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Infections and infestations
Streptococcal infection
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.24%
8/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer metastatic
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer recurrent
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma recurrent
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.15%
5/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Immune system disorders
Anaphylactic shock
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.24%
8/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.18%
6/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.15%
5/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Psychiatric disorders
Depression
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Psychiatric disorders
Bipolar disorder
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Psychiatric disorders
Psychotic disorder due to a general medical condition
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Psychiatric disorders
Suicide attempt
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Cerebral infarction
|
0.24%
8/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Lacunar infarction
|
0.15%
5/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Dizziness
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Basilar artery occlusion
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Brain stem infarction
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Parkinson's disease
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Eye disorders
Cataract
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Eye disorders
Glaucoma
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Eye disorders
Retinal artery occlusion
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Cardiac failure
|
0.42%
14/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.24%
8/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.18%
6/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Angina pectoris
|
0.18%
6/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.18%
6/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
6/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Cardiac failure acute
|
0.15%
5/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Angina unstable
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Cardiomyopathy alcoholic
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Vascular disorders
Aortic aneurysm
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Vascular disorders
Hypertension
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Vascular disorders
Hypertensive emergency
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Vascular disorders
Shock haemorrhagic
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.24%
8/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia chronic
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Melaena
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Superior mesenteric artery syndrome
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Hepatobiliary disorders
Cholangitis
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rapidly progressive osteoarthritis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.27%
9/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.21%
7/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Renal and urinary disorders
Renal impairment
|
0.15%
5/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Renal and urinary disorders
Renal failure
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Renal and urinary disorders
Azotaemia
|
0.09%
3/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Renal and urinary disorders
End stage renal disease
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
General disorders
Death
|
0.18%
6/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
General disorders
General physical health deterioration
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
General disorders
Sudden death
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
General disorders
Chest discomfort
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
General disorders
Drowning
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
General disorders
Oedema
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
General disorders
Oedema peripheral
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
General disorders
Pyrexia
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Investigations
Blood glucose increased
|
0.06%
2/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Investigations
Blood potassium increased
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Investigations
White blood cell count increased
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.21%
7/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
6/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.12%
4/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Injury
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.03%
1/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
Other adverse events
| Measure |
Trazenta®
n=3372 participants at risk
Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
|
|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.5%
184/3372 • For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place