Initial /

Date of
Date of Follow- Phas
SUSAR Case Number Trial ID Product
report up e
(=day 0)
number
[Blinded Oral
Semaglutide-
29-Jan-20 22JAN2020 708979 Initial EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
6-Mar-20 27-Feb-20 712954 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
9-Mar-20 28FEB2020 714308 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
10-Mar-20 29FEB2020 716028 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
11-Mar-20 03MAR2020 711258 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
12-Mar-20 4-Mar-20 714606 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
7-Apr-20 26-Mar-20 708449 4 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
8-Apr-20 31MAR2020 709428 4 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
8-Apr-20 31MAR2020 712954 3 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
8-Apr-20 02APR2020 714308 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
8-Apr-20 31MAR2020 720509 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
9-Apr-20 7-Apr-20 721768 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]

[Blinded Oral
Semaglutide-
13-Apr-20 3-Apr-20 718241 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]

[Blinded Oral
Semaglutide-
13-Apr-20 9-Apr-20 723376 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
16-Apr-20 9-Apr-20 714618 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
17-Apr-20 10-Apr-20 718241 3 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
 [Blinded Oral
Semaglutide-
17-Apr-20 9-Apr-20 718798 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
17-Apr-20 14-Apr-20 723376 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
21-Apr-20 17-Apr-20 723376 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
21-Apr-20 17-Apr-20 724389 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
22-Apr-20 13-Apr-20 723715 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
23-Apr-20 21-Apr-20 724389 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
27-Apr-20 23-Apr-20 725585 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
4-May-20 24-Apr-20 711258 3 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
4-May-20 30-Apr-20 725809 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
6-May-20 30-Apr-20 719704 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
6-May-20 28-Apr-20 720509 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
6-May-20 27-Apr-20 724680 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
6-May-20 28-Apr-20 726038 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
11-May-20 7-May-20 727744 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
13-May-20 6-May-20 709428 5 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
15-May-20 7-Apr-20 721768 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
15-May-20 6-May-20 727337 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
15-May-20 12-May-20 728210 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
 [Blinded Oral
Semaglutide-
18-May-20 11-May-20 702437 3 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
18-May-20 8-May-20 727751 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
18-May-20 14-May-20 728800 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
20-Jul-20 16-Jul-20 711991 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
21-Jul-20 13-Jul-20 738734 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
22-Jul-20 14-Jul-20 737238 1 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
22-Jul-20 16-Jul-20 737472 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
23-Jul-20 14-Jul-20 708979 4 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
23-Jul-20 13-Jul-20 712954 4 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
23-Jul-20 14-Jul-20 730185 3 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
24-Jul-20 21-Jul-20 728210 3 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
28-Jul-20 24-Jul-20 711991 2 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
30-Jul-20 23-Jul-20 712954 5 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
Semaglutide-
30-Jul-20 20-Jul-20 742149 0 EX9924-4473 3B
(Blinded Oral
Semaglutide)]
[Blinded Oral
EX9924- Semaglutide-
13-Aug-20 6-Aug-20 705237 4 3B
4473 (Blinded Oral
Semaglutide)]
[Blinded Oral
EX9924- Semaglutide-
20-Oct-20 16-Oct-20 754100 4 3B
4473 (Blinded Oral
Semaglutide)]
[Blinded Oral
EX9924- Semaglutide-
20-Oct-20 16-Oct-20 760546 1 3B
4473 (Blinded Oral
Semaglutide)]
[Blinded Oral
EX9924- Semaglutide-
21-Oct-20 13-Oct-20 757680 1 3B
4473 (Blinded Oral
Semaglutide)]
[Blinded Oral
EX9924- Semaglutide-
6-Nov-20 4-Nov-20 754100 7 3B
4473 (Blinded Oral
Semaglutide)]
 [Blinded Oral
EX9924- Semaglutide-
6-Nov-20 29-Oct-20 764252 0 3B
4473 (Blinded Oral
Semaglutide)]
[Blinded Oral
EX9924- Semaglutide-
9-Nov-20 5-Nov-20 764122 1 3B
4473 (Blinded Oral
Semaglutide)]
[Blinded Oral
EX9924- Semaglutide-
9-Nov-20 30-Oct-20 764458 0 3B
4473 (Blinded Oral
Semaglutide)]
 Fatal or
SAE HUSM EC
Listednes SUSAR Life
Country of origin Causality (unless otherwise Notification
s (Y/N) threateni
specified) Date
ng

[Probable/Possible
KOREA, REPUBLIC OF [Unlisted] Yes [No] [Cholecystitis]
]

[Blood glucose
TURKEY [Possible/Possible] [Unlisted] Yes [No]
abnormal]

TURKEY [Unlikely/Possible] [Unlisted] Yes [No] [Dermatitis]

[Cardiac failure
UNITED STATES [Possible/Unlikely] [Unlisted] Yes [No]
congestive]

[Coronary artery
[Probable/Unlikely]
[Unlisted] [No] disease] [Left
INDIA Yes
[Unlisted] [No] ventricular
[Probable/Unlikely]
dysfunction]
[Possible/Possible] [Pancreatitis
[Unlisted] [No]
ISRAEL Yes acute]
[Listed] [No]
[Possible/Possible] [Cholelithiasis]
[Probable/Unlikely] [Diabetic
  [Unlisted]  [No]  gastroparesis] 
BELGIUM Yes
[Probable/Possible [Unlisted] [No] [Abdominal
] discomfort]

DENMARK [Possible/Unlikely] [Unlisted] Yes [No] [Urinary retention]

[Blood glucose
TURKEY [Possible/Possible] [Unlisted] Yes [No]
abnormal]

TURKEY [Unlikely/Possible] [Unlisted] Yes [No] [Dermatitis]

UNITED STATES [Possible/Unlikely] [Unlisted] Yes [No] [Colitis]

INDIA [Possible/Unlikely] [Unlisted] Yes [Yes] [Death]

[Impaired gastric
emptying] 
[Possible/Unlikely]  [Unlisted]  [No] 
[Pancreatic
[Unlikely/Unlikely] [Unlisted]  [No] 
UNITED STATES Yes atrophy]  [Acute
 [Unlikely/Unlikely]  [Unlisted]  [No] 
kidney injury] 
[Unlikely/Unlikely] [Unlisted] [No]
[Pancreatic
pseudocyst]

CZECH REPUBLIC [Possible/Unlikely] [Unlisted] Yes [Yes] [Epilepsy]

[Blood creatine
UNITED STATES [Unlikely/Possible] [Unlisted] Yes [No]
increased]

[Impaired gastric
[Possible/Unlikely]  [Unlisted]  [No] 
UNITED STATES Yes emptying]  [Acute
[Unlikely/Unlikely] [Unlisted] [No]
kidney injury]
 [Bile duct stone] 
[Unlikely/Possible]  [Unlisted]  [No]  [Cholangitis
TAIWAN, PROVINCE OF CHINA
[Unlikely/Possible]  [Unlisted]  Yes [No]  acute] 
[Unlikely/Possible] [Unlisted] [No] [Obstructive
pancreatitis]

CZECH REPUBLIC [Possible/Unlikely] [Unlisted] Yes [Yes] [Epilepsy]

CZECH REPUBLIC [Possible/Unlikely] [Unlisted] Yes [Yes] [Epilepsy]

[Acute myocardial
JAPAN [Possible/Unlikely] [Unlisted] Yes [Yes]
infarction]

[Possible/Unlikely]  [Unlisted]  [No]  [Tachycardia] 

UNITED STATES [Possible/Unlikely]  [Unlisted]  Yes [No]  [Hypotension] 
[Unlikely/Unlikely] [Unlisted] [No] [Pyrexia]

[Acute myocardial
JAPAN [Possible/Unlikely] [Unlisted] Yes [Yes]
infarction]

[Neuroendocrine
UNITED STATES [Possible/Unlikely] [Unlisted] Yes [Yes]
tumour]

[Coronary artery
[Probable/Unlikely]
[Unlisted]  [No]  disease]  [Left
INDIA   Yes
[Unlisted] [No] ventricular
[Probable/Unlikely]
dysfunction]

[Coronary artery
UNITED STATES [Possible/Unlikely] [Unlisted] Yes [Yes]
restenosis]

[Acute kidney
THAILAND [Possible/Unlikely] [Unlisted] Yes [No]
injury]

UNITED STATES [Possible/Unlikely] [Unlisted] Yes [No] [Colitis]

[Cerebral
INDIA [Possible/Unlikely] [Unlisted] Yes [No]
infarction]

UNITED STATES [Possible/Unlikely] [Unlisted] Yes [No] [Dyspnoea]

[Not
UNITED STATES [Unlisted] Yes [Yes] [Death]
Reported/Unlikely]

DENMARK [Possible/Unlikely] [Unlisted] Yes [No] [Urinary retention]

INDIA [Possible/Unlikely] [Unlisted] Yes [Yes] [Death]

UNITED STATES [Possible/Unlikely] [Unlisted] Yes [No] [Hypotension]

ISRAEL [Possible/Unlikely] [Unlisted] Yes [Yes] [Hypoglycaemia]

   [Decreased
[Unlisted]  [No] 
[Probable/Unlikely] appetite] 
[Unlisted]  [No] 
JAPAN   Yes [Dehydration] 
[Listed]  [No] 
[Probable/Unlikely] [Nausea] 
[Unlisted] [No]
  [Asthma]

UNITED STATES [Unlikely/Possible] [Unlisted] Yes [No] [Cholecystitis]

[Acute myocardial
UNITED STATES [Probable/Unlikely] [Unlisted] Yes [Yes]
infarction]

[Pancreatitis
[Unlikely/Possible]  [Unlisted]  [Yes] 
TURKEY Yes acute] 
[Unlikely/Possible] [Listed] [Yes]
[Cholelithiasis]

INDIA [Possible/Unlikely] [Unlisted] Yes [No] [Angina unstable]

RUSSIAN
[Possible/Unlikely] [Unlisted] Yes [No] [Pneumonia]
FEDERATION

RUSSIAN
[Possible/Unlikely] [Unlisted] Yes [No] [Ischaemic stroke]
FEDERATION

KOREA, REPUBLIC [Probable/Possible

[Unlisted] Yes [No] [Cholecystitis]
OF ]

[Blood glucose
TURKEY [Possible/Possible] [Unlisted] Yes [No]
abnormal]

[Obstructive
UNITED STATES [Possible/Possible] [Unlisted] Yes [No]
pancreatitis]

[Hypoglycaemic
ISRAEL [Possible/Unlikely] [Unlisted] Yes [Yes]
unconsciousness]

[Obstructive
[Unlikely/Possible]  [Unlisted]  [Yes] 
TURKEY Yes pancreatitis] 
[Unlikely/Possible] [Listed] [Yes]
[Cholelithiasis]

TURKEY [Possible/Possible] [Unlisted] Yes [No] [Vomiting]

INDIA [Probable/Unlikely] [Unlisted] Yes [No] [Dyspnoea]

UNITED STATES [Probable/Unlikely] [Unlisted] Yes [No] [Colon adenoma]

INDIA [Possible/Unlikely] [Unlisted] Yes [Yes] [Cardiac arrest]

[Road traffic
UNITED STATES [Possible/Unlikely] [Unlisted] Yes [Yes]
accident]

RUSSIAN [Pancreatitis
[Possible/Unlikely] [Unlisted] Yes [No]
FEDERATION acute]

INDIA [Possible/Unlikely] [Unlisted] Yes [Yes] [Cardiac arrest]

 BRAZIL [Possible/Possible] [Unlisted] Yes [No] [Hypoglycaemia]

MEXICO [Unlikely/Possible] [Unlisted] Yes [No] [Acute abdomen]

[Possible/Unlikely] [Unlisted] [No] [Chest pain]

UNITED STATES Yes
[Possible/Unlikely] [Unlisted] [No] [Dyspnoea]