FORMULATION DEVELOPMENT AND EVALUATION OF CARVEDILOL PHOSPHATE GASTRO RETENTI...
A study on metfromin
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A study on Me
(1, 1-Dimethylbiguanide
reported adverse events as observed in
Eudravigilance database
Contract Research Organization
NIVETHA CHELLAPATHY
07.07.2016
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A study on Metformin
Dimethylbiguanidemonohydrochloride)
reported adverse events as observed in
Eudravigilance database
Contract Research Organization / Terzetto Pharma Metrics
CHELLAPATHY AND BANU PRIYA
Main, Horamavu, Bangalore 560043
monohydrochloride)
reported adverse events as observed in
3. Terzetto Pharma Metrics Private Limited
A study on Metformin (1, 1
monohydrochloride) reported adverse events as observed in
Eudravigilance database
Abstract
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma glucose
To study the adverse reaction reported for metformin in different type of SOC (System
Organ Classification). Method :
Database of suspected adverse drug reaction reports. These data are segregated into
individual cases and cases based on reaction groups such as age, sex, group and
geographic origin.
Introduction
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma gluc
Reference source not found.
Terzetto Pharma Metrics Private Limited | 142/2,2nd
Main, Horamavu, Bangalore 560043
| www.tpmet.com
A study on Metformin (1, 1-Dimethylbiguanide
monohydrochloride) reported adverse events as observed in
Eudravigilance database
antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma glucose
o study the adverse reaction reported for metformin in different type of SOC (System
Method : Data was extracted and complied from the European
Database of suspected adverse drug reaction reports. These data are segregated into
individual cases and cases based on reaction groups such as age, sex, group and
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma gluc
Reference source not found.)
.
Main, Horamavu, Bangalore 560043
Dimethylbiguanide
monohydrochloride) reported adverse events as observed in
antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma glucose. Objective :
o study the adverse reaction reported for metformin in different type of SOC (System
ata was extracted and complied from the European
Database of suspected adverse drug reaction reports. These data are segregated into
individual cases and cases based on reaction groups such as age, sex, group and
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma glucose(
Error!
4. Terzetto Pharma Metrics Private Limited
Therapeutic Class: Biguanides
Chemical Name: 1, 1-Dimethylbiguanide monohydrochloride
Molecular Formula: C4H
Mechanism of action
Metformin decreases hepatic glucose production, decreases intestinal absorption of
glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and
utilization.
Pharmacokinetics
The absolute bioavailability of a Metformin
fasting conditions is approximately 50% to 60%.Food decreases the extent of and slightly
delays the absorption of Metformin. 90% of the absorbed drug is eliminated via the renal
route within the first 24 hours, with
hours. In blood, the elimination half
source not found.)
.
In 1957, metformin was studied in several trials in
glucose in patients with type 2 diabetes.
Company and initially it was prescribed in
acidosis and deaths increased, Metformin was removed from USA and many other
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Biguanides
Dimethylbiguanide monohydrochloride
H11N5. HCI
Metformin decreases hepatic glucose production, decreases intestinal absorption of
glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and
The absolute bioavailability of a Metformin hydrochloride 500 mg tablet given under
fasting conditions is approximately 50% to 60%.Food decreases the extent of and slightly
delays the absorption of Metformin. 90% of the absorbed drug is eliminated via the renal
route within the first 24 hours, with a plasma elimination half-life of approximately 6.2
hours. In blood, the elimination half-life is approximately 17.6 hours(
Error! Reference
studied in several trials in Paris and has shown to lower blood
glucose in patients with type 2 diabetes. Metformin was manufactured by small
and initially it was prescribed in France and Scotland. As number of lactic
increased, Metformin was removed from USA and many other
Main, Horamavu, Bangalore 560043
Metformin decreases hepatic glucose production, decreases intestinal absorption of
glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and
hydrochloride 500 mg tablet given under
fasting conditions is approximately 50% to 60%.Food decreases the extent of and slightly
delays the absorption of Metformin. 90% of the absorbed drug is eliminated via the renal
life of approximately 6.2
Error! Reference
and has shown to lower blood
Metformin was manufactured by small France
As number of lactic
increased, Metformin was removed from USA and many other
5. Terzetto Pharma Metrics Private Limited
countries. Metformin was approved in Canada in 1972
found.)
, but did not receive approval by the
for type 2 diabetes until 1994.
Glucophage was the first branded formulation of metformin to be marketed in the United
States, beginning on March 3, 1995.
most influential has been the UK Pro
As a result, metformin rose
diabetes. The drug’s anti
confirmed. In 2012 diabetes
drug of the first choice for all
Manufacturer Information
Metformin hydrochloride
by Bristol Myers Squibb,
Pharm, Aurobindo Pharma Ltd
Ltd,Sandoz, Sun Pharm Inds
Inds (in),Ivax Sub Teva Pharms
Provident, Nostrum Pharms Llc
Ltd, Granules India, Sun Pharm Inds Inc
Pharms Inc, Glenmark Generics
Labs,Amneal Pharms Ny
Pharma, Sun Pharm Inds Ltd
Ltd, Takeda Pharms Use, Teva Pharms
Ab, and Merck Sharp Dohme
129 patent family members in 33 countries
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Metformin was approved in Canada in 1972(
Error! Reference source not
but did not receive approval by the U.S. Food and Drug Administration
for type 2 diabetes until 1994. Produced under license by Bristol
Glucophage was the first branded formulation of metformin to be marketed in the United
States, beginning on March 3, 1995. Many studies were performed, and among them the
most influential has been the UK Prospective Diabetes study.
rose as the first choice of treatment for obese patient with type 2
The drug’s anti-atherosclerotic and cardio protective effects have b
diabetes experts in USA and Europe declared that metformin is the
drug of the first choice for all patients with type 2 diabetes(Error! Reference source not found.
Information
Metformin hydrochloride is the generic ingredient in sixteen branded drugs marketed
, Apotex, Ranbaxy Labs Ltd, Torrent Pharms
Aurobindo Pharma Ltd, Watson Labs Inc, Cspc Ouyi Pharm Co
Sun Pharm Inds, Torrent Pharms Ltd, Teva, Atlas Pharms Llc
Ivax Sub Teva Pharms, Santarus Inc, Indicus Pharma, Impax Labs
Nostrum Pharms Llc, Zydus Pharms Use, Watson Labs Florida
Sun Pharm Inds Inc, Actavis Labs Fl Inc, Mylan Pharms
Glenmark Generics, Chartwell Life Sic, Andrx Labs Llc
Amneal Pharms Ny, Alkem, Zydus Hlthcare, Dr Reddys Labs Inc
Sun Pharm Inds Ltd, Inventia Hlthcare, Aurobindo, Macleods Pharms
Teva Pharms Use, Novo Nordisk Inc, Sb Pharmco
Merck Sharp Dohme, and is included in eigthy-five NDAs.. This ingredient has
129 patent family members in 33 countries(
Error! Reference source not found.
Main, Horamavu, Bangalore 560043
Error! Reference source not
Food and Drug Administration (FDA)
Bristol-Myers Squibb,
Glucophage was the first branded formulation of metformin to be marketed in the United
ormed, and among them the
as the first choice of treatment for obese patient with type 2
effects have been
experts in USA and Europe declared that metformin is the
Error! Reference source not found.)
.
is the generic ingredient in sixteen branded drugs marketed
Torrent Pharms, Mylan , Torrent
Cspc Ouyi Pharm Co, Ipca Labs
Atlas Pharms Llc, Sun Pharm
Impax Labs, Elizabeth,
Watson Labs Florida, Barr,Lupin
Mylan Pharms Inc,Sciegen
Andrx Labs Llc, Watson
Dr Reddys Labs Inc, Marksans
Macleods Pharms
Sb Pharmco, Astrazeneca
. This ingredient has
Error! Reference source not found.)
.
6. Terzetto Pharma Metrics Private Limited
Current patent holders
Ranbaxy Laboratories Limited, New Delhi
source not found.)
Torrent Pharm,Ahmedabad
Takeda pharms, USA – May 12, 2009
Pharmacoeconomics
Records of the Drug Controller General (India) show that between 1961 and February
2013, approved a total of 1,125 FDC formulations. The first metformin FDC was
approved in November 1996. Since then, of the 42 anti
metformin formulations.
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
1,144 anti-diabetes products in the market. Of these, 575 were FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/57
anti-diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
anti-diabetes SDFs.
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
1,144 anti-diabetes products in the market. Of these, 575 we
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/575) of the
anti-diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
anti-diabetes SDFs(
Error! Reference source not found.
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Current patent holders
Ranbaxy Laboratories Limited, New Delhi-Patent NO : 6559187(
Error! Refere
Ahmedabad – Approval date Dec,30 /2009
May 12, 2009
Records of the Drug Controller General (India) show that between 1961 and February
2013, approved a total of 1,125 FDC formulations. The first metformin FDC was
approved in November 1996. Since then, of the 42 anti-diabetes FDCs approved, 25 are
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
diabetes products in the market. Of these, 575 were FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/57
diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
diabetes products in the market. Of these, 575 were FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/575) of the
diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
Error! Reference source not found.)
.
Main, Horamavu, Bangalore 560043
Error! Reference
Records of the Drug Controller General (India) show that between 1961 and February
2013, approved a total of 1,125 FDC formulations. The first metformin FDC was
diabetes FDCs approved, 25 are
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
diabetes products in the market. Of these, 575 were FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/575) of the
diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
re FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/575) of the
diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
7. Terzetto Pharma Metrics Private Limited
Indian data shows that metformin FDCs dominated over metformin SDFs by a ratio of
3:1 between the years 2007
diabetes drugs sold in volume.
In 2012, annual sales volume of metformin FDCs is 455.4(millions of unit), but SDFs
sales volume is 148.0(millions of units). Countries like England and Australia
(15.60) annual sale is more than the FDCs annual sale (0.30)
not found.)
.
Data collection
The drug substance information was extracted and compiled from the European database
of suspected adverse drug reaction report
information on metformin was updated within years 2013 to 2016.
The information available in the above website was collected from adverse drug reactions
of substances, stating the data available for
individual cases and cases based on reaction groups such as age, sex, reporter group and
geographic origin.
Interpretation
Based on the data collected from the European database of suspected adverse drug
reaction of Metformin, 15,375 ADR cases
group between 18-64 yrs (
More female patients (51.1%) had experienced adverse drug
(43.5%). Among these cases
ADR than European economic area
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Indian data shows that metformin FDCs dominated over metformin SDFs by a ratio of
3:1 between the years 2007-’12. In 2012, metformin FDCs comprised 56% of oral
diabetes drugs sold in volume.
In 2012, annual sales volume of metformin FDCs is 455.4(millions of unit), but SDFs
sales volume is 148.0(millions of units). Countries like England and Australia
15.60) annual sale is more than the FDCs annual sale (0.30)(
Error! Reference source
The drug substance information was extracted and compiled from the European database
of suspected adverse drug reaction reports (website: www.adrreports.eu). The
information on metformin was updated within years 2013 to 2016.
The information available in the above website was collected from adverse drug reactions
of substances, stating the data available for metformin. The data w
individual cases and cases based on reaction groups such as age, sex, reporter group and
Based on the data collected from the European database of suspected adverse drug
15,375 ADR cases have been reported. Among these cases, age
yrs (39.5%) and 65-85 yrs (40.9%) maximum cases was reported.
51.1%) had experienced adverse drug reaction than
43.5%). Among these cases non-European economic area (54.3%)
ADR than European economic area(
Error! Reference source not found.
Main, Horamavu, Bangalore 560043
Indian data shows that metformin FDCs dominated over metformin SDFs by a ratio of
’12. In 2012, metformin FDCs comprised 56% of oral
In 2012, annual sales volume of metformin FDCs is 455.4(millions of unit), but SDFs
sales volume is 148.0(millions of units). Countries like England and Australia SDFs
Error! Reference source
The drug substance information was extracted and compiled from the European database
s (website: www.adrreports.eu). The
The information available in the above website was collected from adverse drug reactions
The data was segregated into
individual cases and cases based on reaction groups such as age, sex, reporter group and
Based on the data collected from the European database of suspected adverse drug
been reported. Among these cases, age
maximum cases was reported.
reaction than male patients
has reported more
Error! Reference source not found.)
.
8. Terzetto Pharma Metrics Private Limited
System Organ Classification:
SOC is the highest level of
retrieval. There are 26 SOC.
Etiology (e.g., SOC
Manifestation site (e.g., SOC
Purpose (e.g., SOC
The total Number of cases reported is 34,819.
Classification(SOC), Metabolism and nutrition disorders was found to have reported the
maximum number of cases
age group between
group(54.08%)reported more cases than male patient group(41.20%).
reporting group is HCP(85.50%).The highest frequency of cases was reported from
European Economic area(57.60%).
Second SOC with maximum number of adr reported was General disorders and
administration site conditions, in which more cases reported in age group between 18
64 years 1,320(42.7%) and female
than male patients (42.60%)
non- HCP (26.98%).The highest frequency of cases was reported form Non European
Economic area (66.87%).
In Gastrointestinal Disorder
cases are reported in age group between 18
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System Organ Classification:
is the highest level of the hierarchy that provides the broadest concept for data
There are 26 SOC. SOCs comprise groupings by:
Etiology (e.g., SOC Infections and infestations)
Manifestation site (e.g., SOC Gastrointestinal disorders)
Purpose (e.g., SOC Surgical and medical procedures)
The total Number of cases reported is 34,819.Among 26
Metabolism and nutrition disorders was found to have reported the
maximum number of cases 6,961, in which maximum number of cases
age group between 18-64 years 3,494(50%) and also female patient
group(54.08%)reported more cases than male patient group(41.20%).
reporting group is HCP(85.50%).The highest frequency of cases was reported from
a(57.60%).
Second SOC with maximum number of adr reported was General disorders and
administration site conditions, in which more cases reported in age group between 18
64 years 1,320(42.7%) and female patients (52.76%) reported maximum number of cases
42.60%).Healthcare Professional (70.65%) is significantly high than
26.98%).The highest frequency of cases was reported form Non European
In Gastrointestinal Disorder, 3048 cases were reported. Among the
cases are reported in age group between 18-64 years. Female patients
Main, Horamavu, Bangalore 560043
the hierarchy that provides the broadest concept for data
Among 26 System Organ
Metabolism and nutrition disorders was found to have reported the
maximum number of cases was reported in
and also female patient
group(54.08%)reported more cases than male patient group(41.20%).The highest
reporting group is HCP(85.50%).The highest frequency of cases was reported from
Second SOC with maximum number of adr reported was General disorders and
administration site conditions, in which more cases reported in age group between 18 –
52.76%) reported maximum number of cases
significantly high than
26.98%).The highest frequency of cases was reported form Non European
reported. Among them 1,378(45.21%)
64 years. Female patients group (58.53%) is
9. Terzetto Pharma Metrics Private Limited
significantly high than the male patients
reported by HCP and 56% of cases are reported
2,895 cases was reported in Investigational
under 18-64 years age group and 53.67% cases were reported in female patients
group.67.87% cases was reported by HCP and 1,994(68.87%) cases was reported from
Non European Economic area.
In Renal and Urinary disorders SOC
1,433(50.5%) cases are reported in age group between 64
groups(54%)was significantly high than the male patients group(42%).82.89% case
reported by HCP and 1,554(54.81%) cases was reported from European Economic area.
2,426 cases was reported in Nervous system disorder SOC, in which 1,051(43.32%) cases
reported in age group between 64
patients group and 1,788(73.70%) cases are reported by HCP. Non European Economic
area (57.79%) is highly significant than European Economic
In Injury, poisoning and procedural complications SOC, 2,084 c
them 50% cases are reported in age group between 18
(53.67%) are more significant than male
HCP and 68.52% cases are reported from Non European Economic area.
In Cardiac disorder and psychiatric disorder SOC
age group between 18 –
reported (46% and 49%) significant number of cases than male patient
reported by HCP and 68.5 % of cases are reported from Non European Economic area.
In Respiratory, thoracic and mediastinal disorder, Skin and subcutaneous tissue disorder
and Vascular disorder SOC, maximum number of cases are reported in age group
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significantly high than the male patients group (38.25%). 2,332(76.5%) cases was
reported by HCP and 56% of cases are reported from Non European Economic
2,895 cases was reported in Investigational SOC, in which 43.10% cases are reported
64 years age group and 53.67% cases were reported in female patients
67.87% cases was reported by HCP and 1,994(68.87%) cases was reported from
ropean Economic area.
In Renal and Urinary disorders SOC, 2835 cases were reported. Among them
1,433(50.5%) cases are reported in age group between 64-84 years. Female patients
groups(54%)was significantly high than the male patients group(42%).82.89% case
reported by HCP and 1,554(54.81%) cases was reported from European Economic area.
2,426 cases was reported in Nervous system disorder SOC, in which 1,051(43.32%) cases
reported in age group between 64 – 84 years. 55.31% cases are reported in female
patients group and 1,788(73.70%) cases are reported by HCP. Non European Economic
area (57.79%) is highly significant than European Economic area (42.20%).
In Injury, poisoning and procedural complications SOC, 2,084 cases are reported. Among
them 50% cases are reported in age group between 18-64 years.
53.67%) are more significant than male patients (38.77%).1, 655 cases are reported by
HCP and 68.52% cases are reported from Non European Economic area.
In Cardiac disorder and psychiatric disorder SOC, 43.1% and 59.8% cases are reported in
64 years respectively. In both SOC, Female patients group
46% and 49%) significant number of cases than male patient
ported by HCP and 68.5 % of cases are reported from Non European Economic area.
In Respiratory, thoracic and mediastinal disorder, Skin and subcutaneous tissue disorder
and Vascular disorder SOC, maximum number of cases are reported in age group
Main, Horamavu, Bangalore 560043
38.25%). 2,332(76.5%) cases was
European Economic area.
SOC, in which 43.10% cases are reported
64 years age group and 53.67% cases were reported in female patients
67.87% cases was reported by HCP and 1,994(68.87%) cases was reported from
reported. Among them
84 years. Female patients
groups(54%)was significantly high than the male patients group(42%).82.89% cases was
reported by HCP and 1,554(54.81%) cases was reported from European Economic area.
2,426 cases was reported in Nervous system disorder SOC, in which 1,051(43.32%) cases
. 55.31% cases are reported in female
patients group and 1,788(73.70%) cases are reported by HCP. Non European Economic
42.20%).
ases are reported. Among
64 years. Female patients
cases are reported by
HCP and 68.52% cases are reported from Non European Economic area.
59.8% cases are reported in
64 years respectively. In both SOC, Female patients group
46% and 49%) significant number of cases than male patients.80% cases are
ported by HCP and 68.5 % of cases are reported from Non European Economic area.
In Respiratory, thoracic and mediastinal disorder, Skin and subcutaneous tissue disorder
and Vascular disorder SOC, maximum number of cases are reported in age group
10. Terzetto Pharma Metrics Private Limited
between 18 – 64 years and 54.4% are reported in female patient group. Maximum
numbers of cases are reported by HCP in Non European Economic area.
In Blood and lymphatic system disorder and Infection and infestations
cases are reported in 65-84 years
49.5% cases are reported in male patients whereas in Infection and infestations 57.1
cases are reported in female patients. 65
and 73.7% cases are reported fro
In Eye disorder, Hepatobiliary disorder and Musculoskeletal and connective tissue
disorder 47.6% cases are reported in age group between 18
Musculoskeletal and connective tissue
patients group whereas in Hepatobiliary disorder maximum number of cases reported in
male patients group (48%). Maximum
European Economic area.
40-50% cases in Pregnancy, puerpe
medical procedures are reported in age group between 18
reported in female patients group.
European Economic area (
359 cases are reported in
polyps) SOC, in which 42.61% cases reported in 65
number of cases are reported both in male and female pa
reported by HCP. 74.9% cases reported from Non European Economic area.
Congenital, familial and genetic disorder, Endocrine disorder, Immune system disorder,
Product issues and Reproductive system and breast disorder in thes
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64 years and 54.4% are reported in female patient group. Maximum
reported by HCP in Non European Economic area.
In Blood and lymphatic system disorder and Infection and infestations, 51.7
84 years age group. In Blood and lymphatic system disorder
49.5% cases are reported in male patients whereas in Infection and infestations 57.1
are reported in female patients. 65 – 86% of reports were reported by HCP.53.7 %
are reported from Non European Economic area.
In Eye disorder, Hepatobiliary disorder and Musculoskeletal and connective tissue
disorder 47.6% cases are reported in age group between 18-64 years. In Eye disorder and
Musculoskeletal and connective tissue disorder 55.8% cases were reported in female
patients group whereas in Hepatobiliary disorder maximum number of cases reported in
48%). Maximum numbers of cases were reported by HCP from Non
50% cases in Pregnancy, puerperium and perinatal conditions and Surgical and
medical procedures are reported in age group between 18- 64 years and 68% cases
reported in female patients group. Maximum numbers of cases are reported by HCP. Non
area (68%) is highly significant than European Economic area.
359 cases are reported in Neoplasm, benign, malignant and unspecified(incl cysts and
polyps) SOC, in which 42.61% cases reported in 65-85 years age group and equal
number of cases are reported both in male and female patients group. 61% of cases are
74.9% cases reported from Non European Economic area.
, familial and genetic disorder, Endocrine disorder, Immune system disorder,
Product issues and Reproductive system and breast disorder in these SOC 41.8% cases
Main, Horamavu, Bangalore 560043
64 years and 54.4% are reported in female patient group. Maximum
reported by HCP in Non European Economic area.
, 51.7% and 41.3%
age group. In Blood and lymphatic system disorder
49.5% cases are reported in male patients whereas in Infection and infestations 57.1%
86% of reports were reported by HCP.53.7 %
In Eye disorder, Hepatobiliary disorder and Musculoskeletal and connective tissue
64 years. In Eye disorder and
% cases were reported in female
patients group whereas in Hepatobiliary disorder maximum number of cases reported in
reported by HCP from Non
rium and perinatal conditions and Surgical and
64 years and 68% cases
reported by HCP. Non
ficant than European Economic area.
, benign, malignant and unspecified(incl cysts and
85 years age group and equal
tients group. 61% of cases are
74.9% cases reported from Non European Economic area.
, familial and genetic disorder, Endocrine disorder, Immune system disorder,
e SOC 41.8% cases
11. Terzetto Pharma Metrics Private Limited
are reported in 18 – 64 years age group and significant number cases are reported in
female patients. Maximum
Familial and genetic disorder in
European Economic area.
Least number of cases reported in following SOCs ,
circumstances SOC, 43.7% and 50.6% cases are reported in 18
51.8% of cases are reported in female patients. Maximum
by HCP and 76.8% cases are reported from Non European Economic area.
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64 years age group and significant number cases are reported in
female patients. Maximum numbers of cases are reported by HCP. Except Congen
disorder in all SOC maximum number of cases reported from Non
European Economic area.
Least number of cases reported in following SOCs , Ear and labyrinth disorder and Social
circumstances SOC, 43.7% and 50.6% cases are reported in 18-64 years age group.
ses are reported in female patients. Maximum numbers of cases are
by HCP and 76.8% cases are reported from Non European Economic area.
Main, Horamavu, Bangalore 560043
64 years age group and significant number cases are reported in
reported by HCP. Except Congenital,
all SOC maximum number of cases reported from Non
Ear and labyrinth disorder and Social
64 years age group.
numbers of cases are reported
by HCP and 76.8% cases are reported from Non European Economic area.
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