Trial Outcomes & Findings for Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus (NCT NCT01650259)
NCT ID: NCT01650259
Last Updated: 2019-09-18
Results Overview
An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied".
Recruitment status
COMPLETED
Target enrollment
4876 participants
Primary outcome timeframe
From start of the treatment until the end of this PMS, i.e. up to week 156
Results posted on
2019-09-18
Participant Flow
In this post marketing surveillance (PMS) study 4876 patients were registered: 2513 patients (Pts.) in Trazenta® Tablets group \& 2363 patients in other Oral Antidiabetic Drug (OAD) group (grp). 2414 out of 2513 patients were treated (trt) with Trazenta® Tablets. For other OAD group only baseline data \& no observation period.
Non-interventional,observational prospective study based on newly collected data under routine medical practice with 1 grp of Pts. treated with long-term daily use of Trazenta® Tablets for evaluation of baseline,safety\& efficacy data \& another grp of Pts. treated with any other oral antidiabetic monotherapy for collection of baseline data only.
Participant milestones
| Measure |
Trazenta® Tablets
Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
|
Other OAD
Patients with type 2 diabetes mellitus who were treated with any other oral antidiabetic monotherapy except Trazenta® tablets
|
|---|---|---|
|
Overall Study
STARTED
|
2513
|
2363
|
|
Overall Study
COMPLETED
|
1470
|
2128
|
|
Overall Study
NOT COMPLETED
|
1043
|
235
|
Reasons for withdrawal
| Measure |
Trazenta® Tablets
Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
|
Other OAD
Patients with type 2 diabetes mellitus who were treated with any other oral antidiabetic monotherapy except Trazenta® tablets
|
|---|---|---|
|
Overall Study
Improvement
|
105
|
0
|
|
Overall Study
Adverse Event
|
127
|
0
|
|
Overall Study
Lack of Efficacy
|
143
|
0
|
|
Overall Study
Lost to Follow-up
|
435
|
0
|
|
Overall Study
Patients had no visit after entry
|
70
|
0
|
|
Overall Study
CRF not collected
|
98
|
82
|
|
Overall Study
Not treated
|
1
|
7
|
|
Overall Study
Other than listed
|
64
|
146
|
Baseline Characteristics
SS
Baseline characteristics by cohort
| Measure |
Trazenta® Tablets
n=2233 Participants
Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
|
Other OAD
n=2128 Participants
Patients with type 2 diabetes mellitus who were treated with any other oral antidiabetic monotherapy except Trazenta® tablets
|
Total
n=4361 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 Years
STANDARD_DEVIATION 12.5 • n=2233 Participants • SS
|
65.3 Years
STANDARD_DEVIATION 12.6 • n=2128 Participants • SS
|
66.0 Years
STANDARD_DEVIATION 12.6 • n=4361 Participants • SS
|
|
Sex: Female, Male
Female
|
929 Participants
n=2233 Participants • SS
|
910 Participants
n=2128 Participants • SS
|
1839 Participants
n=4361 Participants • SS
|
|
Sex: Female, Male
Male
|
1304 Participants
n=2233 Participants • SS
|
1218 Participants
n=2128 Participants • SS
|
2522 Participants
n=4361 Participants • SS
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From start of the treatment until the end of this PMS, i.e. up to week 156Population: Safety Set (SS): SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.
An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied".
Outcome measures
| Measure |
Trazenta® Tablets
n=2235 Participants
Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
|
|---|---|
|
Percentage of Participants With Adverse Drug Reactions (ADRs)
|
10.74 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and 156 week or last observationPopulation: Efficacy Set: A subset of the safety set, which includes all patients in the "safety set" except those who had no available efficacy data and/or who did not suffer from type 2 diabetes mellitus from the safety set.
Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD).
Outcome measures
| Measure |
Trazenta® Tablets
n=2235 Participants
Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
|
|---|---|
|
Change From Baseline in HbA1c at the Last Observation During the Observation Period.
|
-0.67 percentage of HbA1c
Standard Deviation 1.27
|
Adverse Events
Trazenta® Tablets
Serious events: 116 serious events
Other events: 0 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Trazenta® Tablets
n=2235 participants at risk
Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.13%
3/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Infections and infestations
Herpes zoster
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Infections and infestations
Bacterial infection
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Infections and infestations
Gangrene
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Infections and infestations
Urinary tract infection
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.22%
5/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.13%
3/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer recurrent
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Psychiatric disorders
Alcoholism
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Nervous system disorders
Cerebral infarction
|
0.54%
12/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Nervous system disorders
Dementia
|
0.22%
5/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Nervous system disorders
Altered state of consciousness
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Nervous system disorders
Loss of consciousness
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Nervous system disorders
Parkinson's disease
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Nervous system disorders
Syncope
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Eye disorders
Cataract
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Cardiac failure
|
0.18%
4/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
4/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Angina pectoris
|
0.13%
3/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Angina unstable
|
0.13%
3/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Atrial fibrillation
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Atrial flutter
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Cardiac disorders
Prinzmetal angina
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Vascular disorders
Aortic dissection
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Vascular disorders
Circulatory collapse
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Vascular disorders
Deep vein thrombosis
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Vascular disorders
Hypotension
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Vascular disorders
Shock
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Gastrointestinal disorders
Ileus
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Still's disease
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.18%
4/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.13%
3/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
General disorders
Death
|
0.18%
4/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
General disorders
Sudden death
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
General disorders
Sudden cardiac death
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Investigations
Biopsy liver
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Investigations
Blood creatinine increased
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Investigations
Blood urea increased
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Investigations
Blood uric acid increased
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Investigations
White blood cell count decreased
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
3/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.09%
2/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.04%
1/2235 • From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place