Global Quality, Global Safety

CONFIDENTIAL
Date: 25 April 2013 Novo Nordisk
Safety Surveillance Diabetes Version: 1.0
Periodic SUSAR Report Status: Final
Liraglutide, Q1 2013 Page: 1 of 5
Periodic Suspected Unexpected Serious Adverse Reactions (SUSAR) Report
Liraglutide
Q1 2013
(includes blinded trial data)
Confidentiality Statement:
This report may include unblinded adverse event data. This document is a confidential
communication from Novo Nordisk A/S. This document may only be disclosed to duly authorised
representatives of regulatory authorities, as appropriate, under the condition that it is confidential.
No information contained herein may be disclosed without prior written approval from Novo
Nordisk A/S.
Author
Jannik Nielsen
Safety Surveillance Diabetes, Non-Insulin
Global Quality, Global Safety
CONFIDENTIAL
Date: 25 April 2013 Novo Nordisk
Safety Surveillance Diabetes Version: 1.0
Periodic SUSAR Report Status: Final
Liraglutide, Q1 2013 Page: 2 of 5
Table of contents
Page
Table of contents...............................................................................................................................................2
Table of tables...................................................................................................................................................2
1 Introduction...............................................................................................................................................3
2 Line listings................................................................................................................................................3
3 Safety statement ........................................................................................................................................3
3.1 EX2211-3748 LEADER.............................................................................................................4
3.2 Development programme NN8022 (SCALE) ............................................................................4
3.3 Development programme NN2211................................................................................................5
3.4 Overall safety statement.................................................................................................................5
Appendix 1: Line listing of all suspected unexpected serious adverse reactions from the review
period
Table of tables
Page
Table 1 Distribution of SUSAR events in EX2211-3748 LEADER

........................................................4
Table 2 Distribution of SUSAR events in NN8022 (SCALE

)..................................................................5
Table 3 Distribution of SUSAR events in NN2211....................................................................................5
Global Quality, Global Safety
CONFIDENTIAL
Date: 25 April 2013 Novo Nordisk
Safety Surveillance Diabetes Version: 1.0
Periodic SUSAR Report Status: Final
Liraglutide, Q1 2013 Page: 3 of 5
1 Introduction
This periodic safety report is made according to the requirements in the EU clinical trials directive
(Directive 2001/20/EC, 4 April 2001) and Detailed guidance on the collection, verification and
presentation of adverse reaction reports arising from clinical trials on medicinal products for human
use, (CT-3) (2011/C 172/01) and includes line listings of suspected unexpected serious adverse
reactions (SUSARs) and a safety statement. The investigators are continuously informed of
individual cases qualifying as SUSARs. This periodic SUSAR report aggregates the individual
SUSARs reported during Q1 2013. The purpose of this information obligation towards the
investigator is to inform investigators of safety issues in view of detected SUSARs for liraglutide
during Q1 2013.
2 Line listings
The attached line listings presents all SUSARs reported from clinical trials in connection with the
use of liraglutide received by Global Safety, Novo Nordisk A/S in the period 01 Jan 2013 31 Mar
2013. The SUSARs are from all worldwide Novo Nordisk-sponsored clinical trials, where
liraglutide has been used as primary investigational drug. The line listings include
placebo/comparator cases and the data is presented blinded to treatment allocation.
For the development project NN8022 expectedness is evaluated in accordance with current version
of the investigator brochure (IB). For the post-marketing trial EX2211-3748 and all NN2211 trials
Expectedness is evaluated in accordance with the current version of the company core data sheet
(CCDS). It should be noted that expectedness/listedness of a serious adverse drug reaction may
have changed in the period from when it was reported as an expedited report and until this Periodic
SUSAR Report.
The SUSARs have been recorded in the Novo Nordisk A/S global safety database.
Reports from clinical trials are considered to have a causal relationship between the trial product
and the event if assessed possible/probable related by the reporter and/or Novo Nordisk A/S.
All events have been coded by use of MedDRA (Medical Dictionary for Regulatory Activities).
3 Safety statement
During the reporting period, 39 reports including 48 SUSAR events have been received in
connection with the use of liraglutide.
Global Quality, Global Safety
CONFIDENTIAL
Date: 25 April 2013 Novo Nordisk
Safety Surveillance Diabetes Version: 1.0
Periodic SUSAR Report Status: Final
Liraglutide, Q1 2013 Page: 4 of 5
3.1 EX2211-3748 LEADER
In EX2211-3748 (liraglutide in T2DM patients with high cardiovascular risk), 28 SUSAR reports
including 37 SUSARs were received during the reporting period. Table 1 lists the SUSARs
categorised by medical area of interest. The most frequently reported SUSARs were from the
System Organ Class Cardiovascular disorders, which the trial population is at high risk of
developing. Additional reports were observed within the categories of hepatobiliary disorders and
pancreatitis. A total of 1 case (with 2 SUSARs) had fatal outcome; the preferred terms of the fatal
case were: Hepatic cancer metastatic and Abdominal pain.
Table 1 Distribution of SUSAR events in EX2211-3748 LEADER

SUSARs Total
Cardiovascular disorders* 18
Pancreatitis# 2
Hepatobiliary disorders 2
Neoplasms benign, malignant and unspecified
(incl cysts and polyps)
6
Other 9
Grand total 37
The SUSARs are identified by: *MedDRA SMQs: Ischaemic heart disease, Cardiac arrhythmias, Cardiomyopathy,
Cardiac failure, Embolic and thrombotic events, Shock, Torsade de pointes/QT prolongation, Cerebrovascular
disorders and Vasculitis, #MedDRA SMQ Acute Pancreatitis and SOC Hepatobiliary Disorders and
Neoplasms benign, malignant and unspecified (incl cysts and polyps), respectively
The frequency and distribution of the SUSARs does not cause a safety concern in this trial with
more than 9.000 patients randomised. The next meeting in the Data Monitoring Committee will be
held on 17 May 2013.
3.2 Development programme NN8022 (SCALE)
In the NN8022 development programme (liraglutide in obesity), 7 reports including 8 SUSAR
events were received during the reporting period. One report (1 SUSAR) had fatal outcome, which
included the event: Ventricular fibrillation. Table 2 lists the SUSARs by medical area of interest.
Global Quality, Global Safety
CONFIDENTIAL
Date: 25 April 2013 Novo Nordisk
Safety Surveillance Diabetes Version: 1.0
Periodic SUSAR Report Status: Final
Liraglutide, Q1 2013 Page: 5 of 5
Table 2 Distribution of SUSAR events in NN8022 (SCALE

)
SUSAR Total
Hepatobiliary disorders* 3
Investigations* 2
Other 3
Grand total 8
The SUSARs are identified by: *SOC
The frequency and distribution of the SUSARs does not cause a safety concern due to the low
number and type of reports.
3.3 Development programme NN2211
From the NN2211 development program (liraglutide in T2DM), 3 reports including 3 SUSARs
were received during the reporting period. Two SUSAR from NN2211-3916, and one from
NN2211-3924. None of the cases were fatal. Table 3 lists the SUSARs medically area of interest.
Table 3 Distribution of SUSAR events in NN2211
SUSARs Total
Infections and infestations* 1
Vascular disorders* 1
Neoplasms benign, malignant and unspecified
(incl cysts and polyps)*
1
Grand total 3
The SUSARs are identified by: *SOC
The frequency and distribution of the SUSARs does not cause a safety concern.
3.4 Overall safety statement
Overall, based on the reported SUSARs in the period covered by this report, there is no indication
of significant changes to the evolving safety profile of liraglutide. The information does not give
rise to safety concerns that would warrant update of the current safety information in either the
current version of the investigator brochure (IB) for the development project, or the CCDS of
Victoza

.
Date: 18-Apr-2013 06:52:33 2013 Q1 SUSAR Liraglutide Blinded Report #:
Period: 01-Jan-2013 Through 31-Mar-2013
Ingredient: liraglutide, Placebo
Case Number
Country
Source
Age
Sex
Product Name / Form
Daily Dose
[Dose Frequency] Route
Dates of
Treatment or
Treatment
Duration
Event Onset Date
or Time to Onset
Event Verbatim
[Preferred Term]
Ser/UL/Causal
Patient
Outcome
3
Unlocked Case. * SUSAR Event.

Page 1 of 6
Study ID: EX2211-3748 (29)
368132 TURKEY
Clinical Trial
70 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 04-NOV-2011
Ongoing
14-DEC-2012 Not defined mass in the lung [PULMONARY MASS]*
Y / Y / Y
Not recovered
Study ID: EX2211-3748
368531 FINLAND
Clinical Trial
55 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 10-JAN-2012 Ongoing02-JAN-2013 Ventricular tachycardia [VENTRICULAR
TACHYCARDIA]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
368856 UNITED
STATES
Clinical Trial
68 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 08-JUL-2011 Ongoing21-NOV-2012 Unstable angina [ANGINA UNSTABLE]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
369173 UNITED
STATES
Clinical Trial
68 Years
Female
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 01-MAR-2012 to
24-DEC-2012
25-DEC-2012 Right transient ischemic attack [TRANSIENT
ISCHAEMIC ATTACK]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
369443 UNITED
STATES
Clinical Trial
75 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 16-FEB-2012 to
01-JAN-2013
Blinded Blinded 22-JAN-2013 Ongoing
01-JAN-2013 Myocardial Infarction [MYOCARDIAL INFARCTION]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
369729 INDIA
Clinical Trial
74 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 10-AUG-2011 to
26-JAN-2013
14-JAN-2013 Acute Cholecystitis [CHOLECYSTITIS ACUTE]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
369862 CANADA
Clinical Trial
68 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 01-DEC-2011 to
26-JAN-2013
Blinded Blinded 28-JAN-2013 Ongoing
17-JAN-2013 Intermittent Chest pain; not yest diagnosed (NYD)
[CHEST PAIN]*
Y / Y / Y
Not recovered
Study ID: EX2211-3748
370059 UNITED
STATES
Clinical Trial
60 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 02-DEC-2011 to
25-JAN-2013
Blinded Blinded 04-FEB-2013
Ongoing
28-JAN-2013 Non-ST-elevation myocardial infarction which was
shown by EKG [ACUTE MYOCARDIAL
INFARCTION]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
370267 UNITED
KINGDOM
Clinical Trial
70 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 20-FEB-2012
Ongoing
25-JAN-2013 Angina pectoris [ANGINA PECTORIS]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
Date: 18-Apr-2013 06:52:33 2013 Q1 SUSAR Liraglutide Blinded Report #:
Period: 01-Jan-2013 Through 31-Mar-2013
Case Number
Country
Source
Age
Sex
Product Name / Form
Daily Dose
[Dose Frequency] Route
Dates of
Treatment or
Treatment
Duration
Event Onset Date
or Time to Onset
Event Verbatim
[Preferred Term]
Ser/UL/Causal
Patient
Outcome
3
Unlocked Case. * SUSAR Event.

Page 2 of 6
370871 UNITED
STATES
Clinical Trial
64 Years
Female
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 05-JAN-2011 to
07-FEB-2013
08-JAN-2013 Acute Pancreatitis [PANCREATITIS ACUTE]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
371331 UNITED
KINGDOM
Clinical Trial
71 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 09-JUN-2011 to
01-NOV-2012
08-FEB-2013 Obstructing Terminal Ileum Crohns disease [SMALL
INTESTINAL OBSTRUCTION]*
Y / Y / Y
Not recovered
Study ID: EX2211-3748
371914 TURKEY
Clinical Trial
68 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 19-JAN-2012 to
25-JAN-2013
Blinded Blinded 30-JAN-2013 Ongoing
24-JAN-2013 ibs (irritable bowel syndrome) [IRRITABLE BOWEL
SYNDROME]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
3
371924 FRANCE
Clinical Trial
69 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 31-MAY-2011
Ongoing
12-FEB-2013 Worsening of adenocarcinoma of colon [COLON
CANCER]*
Y / Y / Y
Not recovered
Study ID: EX2211-3748
3
371955 UNITED
STATES
Clinical Trial
61 Years
Female
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 21-OCT-2012 to
20-FEB-2013
20-FEB-2013 hyperkalemia [HYPERKALAEMIA]*
Y / Y / Y
Recovered
20-FEB-2013 Acute renal failure [RENAL FAILURE ACUTE]
Y / N / Y
Study ID: EX2211-3748
372003 UNITED
KINGDOM
Clinical Trial
73 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 07-DEC-2010 to
Unknown
18-NOV-2012 Multifocal Hepatocellular Carcinoma Metastatic
[HEPATIC NEOPLASM MALIGNANT]*
Y / Y / Y
Not recovered
18-JAN-2013 Lung metastases [METASTASES TO LUNG]*
Y / Y / Y
18-JAN-2013 Bone metastisies [METASTASES TO BONE]*
Y / Y / Y
Study ID: EX2211-3748
372142 UNITED
STATES
Clinical Trial
65 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 09-MAR-2012 to
15-JAN-2013
14-JAN-2013 Metastatic hepatocellular carcinoma [HEPATIC
CANCER METASTATIC]*
Y / Y / Y
Fatal
07-MAR-2013 Hospital admission for abdominal pain [ABDOMINAL
PAIN]*
Y / Y / Y
Study ID: EX2211-3748
3
372221 CZECH
REPUBLIC
Clinical Trial
66 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 16-NOV-2011 to
28-FEB-2013
28-FEB-2013 Coronary revascularization procedure [CORONARY
REVASCULARISATION]*
Y / Y / Y
Recovered
28-FEB-2013 Acute coronary syndrome with ST elevations [ACUTE
CORONARY SYNDROME]*
Y / Y / Y
Date: 18-Apr-2013 06:52:33 2013 Q1 SUSAR Liraglutide Blinded Report #:
Period: 01-Jan-2013 Through 31-Mar-2013
Case Number
Country
Source
Age
Sex
Product Name / Form
Daily Dose
[Dose Frequency] Route
Dates of
Treatment or
Treatment
Duration
Event Onset Date
or Time to Onset
Event Verbatim
[Preferred Term]
Ser/UL/Causal
Patient
Outcome
3
Unlocked Case. * SUSAR Event.

Page 3 of 6
12-MAR-2013 Coronary revascularization procedure [CORONARY
REVASCULARISATION]*
Y / Y / Y
Study ID: EX2211-3748
3
372591 CANADA
Clinical Trial
76 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 12-MAR-2012 to
Unknown
26-FEB-2013 Hospitalization non-cardiac chest pain
[NON-CARDIAC CHEST PAIN]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
3
372843 SPAIN
Clinical Trial
81 Years
Female
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 24-FEB-2011 to
02-MAR-2013
Blinded Blinded 20-MAR-2013
Ongoing
02-MAR-2013 Cholecystitis [CHOLECYSTITIS]*
Y / Y / Y
Not recovered
Study ID: EX2211-3748
372983 UNITED
STATES
Clinical Trial
54 Years
Female
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 08-MAR-2012
Ongoing
20-JAN-2013 Chest pain [CHEST PAIN]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
373022 AUSTRALIA
Clinical Trial
66 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 22-FEB-2012
Ongoing
25-FEB-2013 Elective coronary artery stenting [CORONARY
ARTERIAL STENT INSERTION]*
Y / Y / Y
Recovered
25-FEB-2013 Worsening angina pectoris [ANGINA PECTORIS]*
Y / Y / Y
Study ID: EX2211-3748
373100 UNITED
STATES
Clinical Trial
55 Years
Female
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 11-MAR-2011 to
20-FEB-2013
Blinded Blinded 27-FEB-2013
Ongoing
20-FEB-2013 Acute gastroenteritis [GASTROENTERITIS]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
373189 TURKEY
Clinical Trial
65 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 03-FEB-2011 to
28-FEB-2013
Blinded Blinded 06-MAR-2013
Ongoing
28-FEB-2013 Unstabil angina [ANGINA UNSTABLE]*
Y / Y / Y
Recovered
05-MAR-2013 Coronary artery stenting [CORONARY ARTERIAL
STENT INSERTION]*
Y / Y / Y
Study ID: EX2211-3748
3
373608 UNITED
STATES
Clinical Trial
70 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 26-DEC-2012 to
Unknown
Blinded Blinded 14-NOV-2011 to
01-DEC-2012
08-DEC-2012 Retroperitoneal mass [RETROPERITONEAL MASS]*
Y / Y / Y
Not recovered
Study ID: EX2211-3748
Date: 18-Apr-2013 06:52:33 2013 Q1 SUSAR Liraglutide Blinded Report #:
Period: 01-Jan-2013 Through 31-Mar-2013
Case Number
Country
Source
Age
Sex
Product Name / Form
Daily Dose
[Dose Frequency] Route
Dates of
Treatment or
Treatment
Duration
Event Onset Date
or Time to Onset
Event Verbatim
[Preferred Term]
Ser/UL/Causal
Patient
Outcome
3
Unlocked Case. * SUSAR Event.

Page 4 of 6
3
373616 UNITED
STATES
Clinical Trial
70 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 14-NOV-2011 to
01-DEC-2012
Blinded Blinded 26-DEC-2012 to
Unknown
06-DEC-2012 Acute diastolic heart failure [CARDIAC FAILURE
ACUTE]*
Y / Y / Y
Not recovered
Study ID: EX2211-3748
373690 GERMANY
Clinical Trial
69 Years
Female
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 12-MAR-2012 to
18-MAR-2013
11-MAR-2013 Small-celled bronchial carcinoma [BRONCHIAL
CARCINOMA]*
Y / Y / Y
Not recovered
Study ID: EX2211-3748
373931 BRAZIL
Clinical Trial
66 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 12-AUG-2012 to
03-MAR-2013
Blinded Blinded 29-MAR-2013
Ongoing
03-MAR-2013 Acute myocardial infarction [ACUTE MYOCARDIAL
INFARCTION]*
Y / Y / Y
Recovered
Study ID: EX2211-3748
373932 GERMANY
Clinical Trial
67 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 01-MAR-2012 to
20-MAR-2013
18-MAR-2013 pancreatitis [PANCREATITIS]*
Y / Y / Y
Not recovered
21-MAR-2013 Suspicion of pancreatic cyst [PANCREATIC CYST]*
Y / Y / Y
Study ID: EX2211-3748
374392 UNITED
STATES
Clinical Trial
80 Years
Male
Blinded Liraglutide vs.
Placebo / Blinded
Blinded
Blinded 06-SEP-2011
Ongoing
15-AUG-2012 Myocardial Infarction [MYOCARDIAL INFARCTION]*
Y / Y / Y
Not Reported
Study ID: EX2211-3748
Study ID: NN2211-3916 (2)
369226 RUSSIAN
FEDERATION
Clinical Trial
71 Years
Male
Blinded Liraglutide as
add-on to existing
diabetes medication /
Blinded
Blinded
Blinded 17-SEP-2012 to
28-JAN-2013
11-JAN-2013 Impairment of blood circulation of 1st finger of a foot
[POOR PERIPHERAL CIRCULATION]*
Y / Y / Y
Recovered
Study ID: NN2211-3916
370867 RUSSIAN
FEDERATION
Clinical Trial
66 Years
Male
Blinded Liraglutide as
add-on to existing
diabetes medication /
Blinded
Blinded
Blinded 20-SEP-2012 to
10-FEB-2013
05-FEB-2013 osteomyelitis of 5 plantar bone of right foot
[OSTEOMYELITIS]*
Y / Y / Y
Recovering/resolving
Study ID: NN2211-3916
Study ID: NN2211-3924 (1)
369709 JAPAN
Clinical Trial
81 Years
Male
Liraglutide FlexPen /
Solution for injection
.9 mg [.9 mg-qd]
Subcutaneous 28-JAN-2012 to
25-JAN-2013
25-JAN-2013 Pulmonary cancer (stage II) [LUNG CARCINOMA
CELL TYPE UNSPECIFIED STAGE II]*
Y / Y / Y
Not recovered
Study ID: NN2211-3924
Date: 18-Apr-2013 06:52:33 2013 Q1 SUSAR Liraglutide Blinded Report #:
Period: 01-Jan-2013 Through 31-Mar-2013
Case Number
Country
Source
Age
Sex
Product Name / Form
Daily Dose
[Dose Frequency] Route
Dates of
Treatment or
Treatment
Duration
Event Onset Date
or Time to Onset
Event Verbatim
[Preferred Term]
Ser/UL/Causal
Patient
Outcome
3
Unlocked Case. * SUSAR Event.

Page 5 of 6
Study ID: NN8022-1839 (6)
368323 DENMARK
Clinical Trial
40 Years
Female
Blinded Liraglutide vs.
placebo / Blinded
Blinded
Blinded 21-JUL-2011 to
Unknown
Blinded Blinded 18-AUG-2011
Ongoing
01-AUG-2012 Acute cholecystitis [CHOLECYSTITIS ACUTE]*
Y / Y / Y
Recovered
01-AUG-2012 Gallstone [CHOLELITHIASIS]*
Y / Y / Y
Study ID: NN8022-1839
370014 IRELAND
Clinical Trial
27 Years
Female
Blinded Liraglutide vs.
placebo / Blinded
Blinded
Blinded 11-AUG-2011 to
21-AUG-2011
24-APR-2012 Chronic cholecystitis [CHOLECYSTITIS CHRONIC]*
Y / Y / Y
Recovered
Study ID: NN8022-1839
371416 SOUTH AFRICA
Clinical Trial
42 Years
Female
Blinded Liraglutide vs.
placebo / Blinded
Blinded
Blinded 27-JUL-2011 to
Unknown
Blinded Blinded AUG-2011 to
06-SEP-2012
04-SEP-2012 Elevated lipase [LIPASE INCREASED]*
Y / Y / Y
Recovered
Study ID: NN8022-1839
372452 SWITZERLAND
Clinical Trial
54 Years
Female
Blinded Liraglutide vs.
placebo / Blinded
Blinded
Blinded 27-AUG-2011 to
Unknown
Blinded Blinded 23-SEP-2011 to
28-FEB-2013
21-FEB-2013 Invasive ductal mamma carcinoma left breast
[BREAST CANCER]*
Y / Y / Y
Not recovered
Study ID: NN8022-1839
372534 POLAND
Clinical Trial
47 Years
Male
Blinded Liraglutide vs.
placebo / Blinded
Blinded
Blinded 27-JUL-2011 to
Unknown
Blinded Blinded 01-SEP-2011
Ongoing
11-JAN-2013 Elevated lipase [LIPASE INCREASED]*
Y / Y / Y
Recovered
Study ID: NN8022-1839
374290 UNITED
STATES
Clinical Trial
67 Years
Male
Blinded Liraglutide vs.
placebo / Blinded
Blinded
Blinded 24-AUG-2011 to
Unknown
Blinded Blinded 21-SEP-2011 to
23-MAR-2013
24-MAR-2013 1. Acute cardiopulmonary arrest, 2. Ventricular
fibrillation [VENTRICULAR FIBRILLATION]*
Y / Y / Y
Fatal
Study ID: NN8022-1839
Study ID: NN8022-3970 (1)
368580 UNITED
STATES
Clinical Trial
61 Years
Male
Blinded Liraglutide for
Sleep Apnoea / Blinded
Blinded
Blinded 06-SEP-2012 to
Unknown
Blinded Blinded 04-OCT-2012 to
01-DEC-2012
21-SEP-2012 Worsening of Vivid dreams with extreme violence
[NIGHTMARE]*
Y / Y / Y
Recovered
Study ID: NN8022-3970
Date: 18-Apr-2013 06:52:33 2013 Q1 SUSAR Liraglutide Blinded Report #:
Period: 01-Jan-2013 Through 31-Mar-2013
Case Number
Country
Source
Age
Sex
Product Name / Form
Daily Dose
[Dose Frequency] Route
Dates of
Treatment or
Treatment
Duration
Event Onset Date
or Time to Onset
Event Verbatim
[Preferred Term]
Ser/UL/Causal
Patient
Outcome
3
Unlocked Case. * SUSAR Event.

Page 6 of 6
Total number of case entries printed: 39
Total number of cases printed: 39