LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation
Conditions: Status Epilepticus
Sponsor: Pfizer

 
L ora pita 
B 3 5 4 1 0 0 3 N O N- I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3 
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data C ollecti o n 
St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 of 3 7 
( A P P E N DI X) 
 
 
L O R A- PI T A ®  I ntr a ve n o us I njecti o n 2 mg Ge ner al I n vesti g ati o n 
N O N-I N T E R V E N TI O N A L ( NI) S T U D Y P R O T O C O L 
 
 
 
 
 
 
 
 
 
 
 
Pfizer Ja pa n I nc. 
 
 
T his d oc u me nt c o ntai ns c o nfi de ntial i nf or mati o n bel o n gi n g t o Pf izer.  E xce pt as ot her wise 
a gree d t o i n writi n g, b y acce pti n g or re vie wi n g t his d oc u me nt, y o u a gree t o h ol d t his 
i nf or mati o n i n c o nfi de nce a n d n ot c o p y or discl ose it t o ot hers (e xce pt w here re q uire d b y 
a p plica ble la w) or use it f or u na ut h orize d p ur p oses.  I n t he e v e nt of a n y act ual or s us pecte d 
b reac h of t his o bli gati o n, Pfizer m ust be pr o m ptl y n otifie d.
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

 
L ora pita 
B 3 5 4 1 0 0 3 N O N- I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3 
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 of 3 7 
 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 of 3 7  
S T U D Y I N F O R M A TI O N  
Title 
L O R A- PI T A ®  I ntra ve n o us I njecti o n 2 m g 
Ge neral I n vesti gati o n 
Pr ot oc ol n u m ber 
B 3 5 4 1 0 0 3 
Pr ot oc ol versi o n i de ntifier 
Ver. 5 
D ate 
0 4 Se pte m ber 2 0 2 3  
Acti ve s u bst a nce 
L oraze pa m 
Me dici n al pr o d uct  
 
L O R A- PI T A ®  I ntra ve n o us I njecti o n 2 m g 
Rese arc h q uesti o n a n d o bjecti ves 
T o e val uate t he safe t y a n d efficac y of 
L O R A- PI T A ®  I ntra ve n o us I njecti o n 2 m g i n 
patie nts wit h stat us e pile ptic us w h o recei ve d 
t his dr u g u n der act ual use c o n diti o ns after 
mar keti n g.  
A ut h or 
  
 
 
 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)
P P D
P P D

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 3 of 3 7  
 
1.  T A B L E O F C O N T E N T S 
1. T A B L E O F C O N T E N T S ....................................................................................................... 3  
2. LI S T O F A B B R E VI A TI O N S ................................................................................................ 6  
3. R E S P O N SI B L E P A R TI E S .................................................................................................... 7  
4. A M E N D M E N T S A N D U P D A T E S ....................................................................................... 7  
5. MI L E S T O N E S ..................................................................................................................... 1 0  
6. R A TI O N A L E A N D B A C K G R O U N D ................................................................................ 1 0  
7. R E S E A R C H Q U E S TI O N A N D O BJ E C TI V E S ........................... ...................................... 1 1 
7. 1. Safet y S pecificati o ns .................................... ...............................................................1 1  
8. R E S E A R C H M E T H O D S .................................................................................................... 1 1  
8. 1. St u d y desi g n ................................................................................................................ 1 1  
8. 2. Setti n g .................................................. ........................................................................ 1 1 
8. 2. 1. Re gistrati o n criteria .......................................................................................... 1 1  
8. 2. 2. E xcl usi o n criteria ..................................... ........................................................ 1 2 
8. 2. 3. St u d y sites ........................................................................................................ 1 2  
8. 2. 4. Pla n ne d st u d y peri o d ................................... ..................................................... 1 2 
8. 2. 5. St u d y pr oce d ures .............................................................................................. 1 2  
8. 2. 6. O bser vati o n peri o d ........................................................................................... 1 2  
8. 3. Varia bles ................................................ ...................................................................... 1 3 
8. 3. 1. Patie nt c haracteristics ....................................................................................... 1 4  
8. 3. 2. A d mi nistrati o n of tar gete d dr u g ........................ ............................................... 1 7 
8. 3. 3. Dr u g t hera p y ( pre me dicati o n a n d c o nc o mita nt me dicati o ns)  .......................... 1 7 
8. 3. 4. N o n- dr u g t hera p y ( T o be c olle cte d o nl y f or patie nts wit h A Es)...................... 1 8  
8. 3. 5. Tests/cli nical la b orat or y tests ........................................................................... 1 8  
8. 3. 6. E n d- of-st u d y ( Disc o nti n uati o n) rec or d ( S u m mar y of t he pa tie nt 
i ncl u di n g Reas o n f or disc o nti n uati o n) ............................................................ 1 9 
8. 3. 7. E val uati o n of stat us e pile pt ic us seiz ure (efficac y e val uati o n) ......................... 1 9  
8. 3. 8. A d verse e ve nts ......................................... ........................................................ 1 9 
8. 4. Data s o urces ................................................................................................................ 2 0  
8. 5. St u d y size .................................................................................................................... 2 0  
8. 5. 1. Pla n ne d sa m ple size .................................... ..................................................... 2 0 
8. 5. 2. Rati o nale f or sa m ple size .............................. ................................................... 2 0 
8. 6. Data ma na ge me nt ........................................................................................................ 2 1  
8. 6. 1. Case re p ort f or ms ( C R Fs)/ Electr o nic data rec or d ....... .................................... 2 1 
8. 6. 2. Rec or d h ol di n g ................................................................................................. 2 1  
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 4 of 3 7  
8. 6. 3. Data c ollecti o n met h o d ( E D C) ......................................................................... 2 2  
8. 6. 4. Patie nt re gistrati o n ( E D C) ................................................................................ 2 2  
8. 6. 5. P oi nts t o c o nsi der f or c o m pleti o n, re visi o n, a n d s u b miss i o n of case 
re p ort f or m ( E D C) .......................................................................................... 2 2 
8. 6. 6. Fi xe d- p oi nt all pati e nts re gistrati o n .................. ............................................... 2 2 
8. 7. Data a nal ysis ................................................................................................................ 2 2  
8. 7. 1. A nal ysis f or safet y e val uati o n ......................... ................................................. 2 3 
8. 7. 2. A nal ysis f or efficac y e val uati o n ...................................................................... 2 3  
8. 8. Q ualit y c o ntr ol .......................................... ................................................................... 2 5 
8. 9. Li mitati o ns of t he researc h met h o ds ........................................................................... 2 5  
8. 1 0. Ot her as pects ........................................... .................................................................. 2 5 
9. P R O T E C TI O N O F H U M A N S U BJ E C T S .......................................................................... 2 5  
9. 1. Patie nt I nf or mati o n ...................................... ................................................................ 2 5 
9. 2. Patie nt C o nse nt ............................................................................................................ 2 6  
9. 3. I nstit uti o nal Re vie w B oar d (I R B)/ Et hics C o m mittee ( E C) ... ...................................... 2 6 
9. 4. Et hical C o n d uct of t he St u d y ....................................................................................... 2 6  
1 0. M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S A N D 
A D V E R S E D R U G R E A C TI O N S ........................................ .............................................. 2 7 
1 0. 1. Re q uire me nts f or rec o r di n g a n d re p orti n g ................................................................ 2 7 
1 0. 2. Re p orti n g peri o d ........................................ ................................................................ 2 8 
1 0. 3. Ca usalit y assess me nt ................................................................................................. 2 8  
1 0. 4. Defi niti o ns of safet y e ve nts ............................ ........................................................... 2 8 
1 0. 4. 1. A d verse e ve nts ............................................................................................... 2 8  
1 0. 4. 2. Seri o us a d verse e ve nts ................................ ................................................... 2 9 
1 0. 4. 3. Sce nari os necessitati n g re p orti n g t o Pfizer Safet y wit h i n 2 4 h o urs ............... 3 1 
1 1. P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y 
R E S U L T S ....................................................... .................................................................... 3 3 
1 2. N A M E, A N D A D D R E S S O F C O N T R A C T O R A S W E L L A S S C O P E O F 
W O R K C O N T R A C T E D ............................................... ..................................................... 3 4 
1 3. A D DI TI O N A L M E A S U R E S T H A T M A Y B E I M P L E M E N T E D B A S E D O N 
T H E S T U D Y R E S U L T S A N D C RI T E RI A F O R D E T E R MI N A TI O N O F T H E 
I NI TI A TI O N ...................................................................................................................... 3 4 
1 4. S C H E D U L E D TI MI N G O F MI L E S T O N E S A N D T H EI R R A TI O N A L E S F O R 
E V A L U A TI O N O F S T U D Y I M P L E M E N T A TI O N S T A T U S A N D R E S U L T S 
A N D R E P O R TI N G T O T H E P M D A ..................................... ........................................... 3 5 
1 5. O T H E R N E C E S S A R Y M A T T E R S .................................................................................. 3 5  
1 5. 1. A me n d me nt of t he St u d y Pr ot oc ol ......................... ................................................... 3 5 
1 5. 2. Acti o ns t o be ta ke n f or a n y pr o ble m or iss ue ............................................................ 3 5  
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 5 of 3 7  
1 6. C O N T A C T I N F O R M A TI O N ....................................... ..................................................... 3 5 
1 6. 1. C o ntact i nf or mati o n f or i n q uiries a b o ut t he st u d y ....... .............................................. 3 5 
1 6. 2. C o ntact i nf or mati o n f or i n q uiries a b o ut t he E D C s yste m ......................................... 3 5  
1 7. R E F E R E N C E S .................................................................................................................. 3 6  
1 8. LI S T O F T A B L E S ............................................ ................................................................. 3 6 
1 9. LI S T O F FI G U R E S ........................................... ................................................................ 3 6 
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S ........................ ................................. 3 6 
A N N E X 2. A D DI TI O N A L I N F O R M A TI O N ............................... .......................................... 3 6 
 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 6 of 3 7  
2.  LI S T O F A B B R E VI A TI O N S 
A b bre viati o n  Defi niti o n  
A E  
A d verse E ve nt  
E D C  
Electr o nic Data Ca pt ure
S p O 2 
O xy g e n Sat urati o n b y  P ulse O xi metry
I L A E  
I nter nati o nal Leag ue A g ai nst E pile ps y
 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 7 of 3 7  
3.  R E S P O N SI B L E P A R TI E S 
T he Ja pa n G o o d P ost- mar keti n g St u d y Practice officer 
4.  A M E N D M E N T S A N D U P D A T E S 
A me n d me nt 
n u m ber 
D ate 
T y pe of 
a me n d me nt 
( S u bsta ntial or 
a d mi nistrati ve)
Pr ot oc ol 
secti o n(s) 
c h a n ge d  
S u m m ar y of 
a me n d me nt(s) 
Re as o n 
Ver. 5 
0 4 
Se pte m ber 
2 0 2 3 
A d mi nistrati ve 
a me n d me nt 
9. 3. 
Descri pti o ns 
e dite d 
C ha n ge d ue t o 
t he re visi o n of 
i nter nal f or mat
1 2 ． 
C o ntract or 
c ha n ge d 
C ha n ge of a 
c o ntract or of 
E D C acc o u nt 
ma na ge me nt 
w or ks 
Ver. 4 
1 8 
N o ve m ber 
2 0 2 2 
S u bsta ntial 
a me n d me nt 
S T U D Y 
I N F O R M A TI O N
De part me nt 
na me of t he 
a ut h or c ha n ge d 
Or ga nizati o nal 
c ha n ge 
5., 8. 2. 2., 8. 6. 1., 
8. 9., 9. 4. 
Ite ms a d de d a n d 
descri pti o ns 
u p date d 
E diti n g of 
descri pti o ns 
6.  
Mi nisterial 
or di na nces a n d 
n otices u p date d 
Partial 
re visi o n of 
mi nisterial 
or di na nces 
8. 6. 6. 
Fi xe d- p oi nt all 
patie nts 
c o nfir mati o n 
met h o d u p date d 
Clearer 
descri pti o n of 
t he fi xe d- p oi nt 
all patie nts 
c o nfir mati o n 
met h o d 
1 0., 1 0. 4. 1., 
1 0. 4. 3. 
Ja pa nese 
tra nslati o n 
c ha n ge d a n d 
descri pti o ns 
e dite d 
C ha n ge d ue t o 
t he re visi o n of 
i nter nal f or mat
Pre vi o us, 1 2. 
Delete d 
(s u bse q ue nt 
secti o n n u m bers 
m o ve d u p) 
E diti n g of 
descri pti o ns 
d ue t o 
n otificati o n of 
“ F or m ulati o n 
a n d 
P u blicati o n of 
Ris k 
Ma na ge me nt 
Pla n,” date d 
1 8 Marc h
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 8 of 3 7  
2 0 2 2 
1 2. 
Sc o pe of w or k 
c o ntracte d 
u p date d, a n d 
descri pti o ns 
e dite d 
E x pa nsi o n of 
t he sc o pe of 
t he c o ntract 
1 6. 1. 
Na me of t he 
de part me nt f or 
i n q uiries 
c ha n ge d, a n d 
descri pti o ns  
e dite d 
Or ga nizati o nal 
c ha n ge 
1 6. 2. 
C o ntact p h o ne 
n u m ber f or 
i n q uiries 
c ha n ge d, a n d 
descri pti o ns 
e dite d 
C ha n ge of t he 
c o ntact p h o ne 
n u m ber f or 
i n q uiries 
Ver. 3. 1 
0 7 J u ne 
2 0 2 2 
A d mi nistrati ve 
a me n d me nt 
C o ver pa ge 
C o m pa n y l o g o 
c ha n ge d 
C ha n ge of t he 
l o g o 
Ver. 3 
1 0 Ma y 
2 0 2 1 
S u bsta ntial 
a me n d me nt 
S T U D Y 
I N F O R M A TI O N
T he a ut h or 
c ha n ge d 
C ha n ge of t he 
pers o n i n 
c har ge 
5. 
T he date of fi nal 
st u d y re p ort 
c ha n ge d 
C ha n ge d ue t o 
t he e xte nsi o n 
of t he pla n ne d 
st u d y peri o d 
8. 2. 2. 
St u d y sites 
c ha n ge d 
Re m o val of 
“ b y s pecialists 
ha vi n g 
k n o wle d ge i n 
t he area of t he 
c o ncer ne d 
disease” i n 
or der t o 
e ns ure t he 
tar get sa m ple 
size 
5., 8. 2. 3. 
T he 
i n vesti gati o n 
peri o d a n d 
re gistrati o n 
peri o d e xte n de d 
E xte nsi o n of 
t he 
i n vesti gati o n 
peri o d a n d 
re gistrati o n 
peri o d b y 1 
year a n d 3 
m o nt hs i n 
or der t o 
e ns ure t he 
tar get sa m ple 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 9 of 3 7  
size 
8. 6. 6. 
Fi xe d- p oi nt all 
patie nts 
re gistrati o n 
met h o d a d de d 
C orrecti o n of 
descri pti o n 
o missi o n 
Ver. 2 
1 0 Oct o ber 
2 0 1 9 
A d mi nistrati ve 
a me n d me nt 
C o ver, S T U D Y 
I N F O R M T A TI O N,
2, . 8. 3. 8., 8. 4., 
8. 6. 1., 8. 6. 3., 8. 7., 
8. 8., 1 1., 1 3. 
Descri pti o ns 
u p date d 
C orrecti o n of 
err ors a n d 
c ha n ge/ 
e diti n g f or 
c o nsiste nc y 
wit h ot her 
secti o ns 
8. 3. 6. 
“ S u m mar y of 
t he patie nt” 
a d de d t o secti o n 
title 
C o nsiste nc y of 
la n g ua ge wit h 
Ta ble 1. 
Varia bles a n d 
sc he d ule of 
o bser vati o n 
1 0. 
Secti o n a d de d 
Descri pti o ns 
i n a se parate 
d oc u me nt 
i ncl u de d i n 
t his pr ot oc ol 
1 3. 
Sc o pe of w or k 
a d de d 
Decisi o n of a 
c o ntract or of 
s o me w or ks 
1 7. 2. 
E- mail a d dress 
c ha n ge d 
C ha n ge of E-
mail a d dress 
of Me di data 
Fi nal 
1 0 Ja n uar y 
2 0 1 9 
N A 
N A 
N A 
N A   
 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 0 of 3 7  
5.  MI L E S T O N E S 
Milest o ne  
Pl a n ne d d ate 
Start of data c ollecti o n 
0 1 Marc h 2 0 1 9  
Start of data c ollecti o n ( d ate of re gistrati o n of t he 
first patie nt re gistere d)  
1 8 N o ve m ber 2 0 1 9 
E n d of data c ollecti o n 
0 2 J u ne 2 0 2 3   
E n d of data c ollecti o n ( date of release of t he 
data base) 
Ar o u n d Dece m ber 2 0 2 3 
Fi nal st u d y re p ort 
Ar o u n d 2 0 2 4 
 
6.  R A TI O N A L E A N D B A C K G R O U N D 
L O R A- PI T A ®   I ntra ve n o us  I njecti o n  2  m g  ( n o n pro prietar y  na me,  l oraze pa m)  is  a 
be nz o diaze pi ne  dr u g  t hat  has  a n a n xi ol ytic  effect,  se dati ve  effect  a n d  a ntic o n v ulsa nt 
effect. I n Ja pa n, its oral f or m ulati o n ( W y pa x ®  Ta blets 0. 5 m g a n d 1. 0 m g) was a p pr o ve d 
i n  1 9 7 7  f or  t he  i n dicati o ns  “a n xiet y,  te nsi o n  a n d  de pressi o n  i n   ner v o us  diseases”  a n d 
“ p h ysical  s y m pt o ms  i n  ps yc h os o ma tic  dis or ders  (a ut o n o mic  i m balance  a n d  car diac 
ne ur osis)  as  well  as  a n xiet y,  te ns i o n  a n d  de pressi o n”  a n d  mar kete d.  L O R A- PI T A®  
I ntra ve n o us  I njecti o n  2  m g  ( herei nafter  referre d  t o  as  L O R A- PI TA)  is  me nti o ne d  as  a 
first-li ne  dr u g  i n  Wester n  g ui deli nes  f or  t he  treat me nt  of  status  e pile ptic us;  h o we ver, 
beca use  it  was  n ot  a p pr o ve d  i n  Ja pa n,  t he  Ja pa n  E pile ps y  S ociet y,  Ja pa nese  S ociet y  of 
C hil d Ne ur ol o g y a n d Ja pa n Ps yc h o- O nc ol o g y S ociet y s u b mitte d a d e vel o p me nt re q uest i n 
2 0 0 9. As a res ult of its re vie w b y t he “ E val uati o n C o m mittee o n  U na p pr o ve d or Off-la bel 
Dr u gs wit h Hi g h Me dical Nee ds,” L O R A- PI T A was j u d ge d t o ha ve hi g h me dical nee ds 
f or  t he  treat me nt  of  stat us  e pile ptic us.  He nce,  t he  de vel o p me nt  of  L O R A- PI T A  was 
u n derta ke n, a n d mar keti n g a p pr o val was gra nte d f or t he i n dicati o n: “ Stat us e pile ptic us.” 
A “ L O R A- PI T A ®  I ntra ve n o us I njecti o n 2 m g Ge neral I n vesti gati o n” will be c o n ducte d t o 
c ollect  a n d  e val uate  t he  safet y  a n d  efficac y  data  of  L O R A- PI T A u n der  act ual  use 
c o n diti o ns i n Ja pa n.  
T his  St u d y  s hall  be  c o n d ucte d  i n   strict  c o m plia nce  wit h  t he  “ M H L W Or di na nce o n t he 
Sta n dar d  f or  P ost- Mar keti n g  St u di es  a n d  Cli nical  Trials  of  Me di cal  Pr o d ucts”  ( M H L W 
Or di na nce  N o.  1 7 1,  date d  Dece m ber  2 0,  2 0 0 4),  t he  “ E nf orce me nt  o f  t he  M H L W 
Or di na nce  o n  t he  Sta n dar d  f or P ost- mar keti n g  St u dies  a n d  Cli nic al  Trials  of    Me dical 
Pr o d ucts”  ( P F S B  N otificati o n  N o.  1 2 2 0 0 0 8,  date d  Dece m ber  2 0,  2 0 0 4),  “ M H L W 
Or di na nce o n t he Sta n dar d f or P ost- mar keti n g Safet y C o ntr ol of Me dical Pr o d ucts, Q uasi-
me dical  Pr o d ucts,  C os metics,  Me dical  De vices,  a n d  Re ge nerati ve  Me dici ne  Pr o d ucts” 
( M H L W  Or di na nce  N o.  1 3 5,  date d  Se pte m ber  2 2,  2 0 0 4),  t he  “ E nf orce me nt  of  t he 
M H L W  Or di na nce  o n  t he  Sta n dar d 
f or  P ost- mar keti n g  Safet y  C o ntr ol  of  Me dical 
Pr o d ucts,  Q uasi- me dical  Pr o d ucts, C os metics,  Me dical  De vices,  a n d  Re ge nerati ve 
Me dici ne  Pr o d ucts”  ( P F S B  N otificati o n  N o.  0 8 1 2- 4,  date d  A u g ust 1 2,  2 0 1 4),  “ M H L W 
Or di na nce t o Partiall y A me n d t he M H L W Or di na nce o n t he Sta n dar d f or P ost- mar keti n g 
St u dies a n d Cli nical Trials of 
Me dical Pr o d ucts” ( M H L W Or di na nc e  N o.  1 1 6,  date d 
Oct o ber 2 6, 2 0 1 7), a n d “ A n n o u nce me n t of t he M H L W Or di na nce t o Partiall y A me n d t he 
M H L W  Or di na nce  o n  t he  Sta n dar d  f or  P ost- mar keti n g  St u dies  a n d  C li nical  Trials  of 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 1 of 3 7  
Me dical Pr o d ucts ( Re gar di n g t he M H L W Or di na nce o n t he Sta n dar d f or P ost- Mar keti n g 
St u dies a n d Cli nical Trials of M e dical Pr o d ucts)” ( P S E H B N otifi cati o n N o. 1 0 2 6- 1, date d 
Oct o ber 2 6, 2 0 1 7). 
 
7.  R E S E A R C H Q U E S TI O N A N D O B J E C TI V E S 
T his  st u d y  i nte n ds  t o  e val uate  t he  safet y  a n d  efficac y  of  L O R A- PI T A  i n  patie nts  w h o 
recei ve d t his dr u g u n der act ual use c o n diti o ns after mar keti n g.  
7. 1.  S afet y S pecific ati o ns 
[I m p ort a nt i de ntifie d ris ks] 
•  Res pirat or y de pressi o n 
•  Car diac arrest 
•  C o ma 
•  Para d o xical reacti o n 
8.  R E S E A R C H M E T H O D S 
8. 1.  St u d y desi g n 
T his st u d y is a m ultice nter c o h o rt st u d y c o n d ucte d i n patie nts recei vi n g L O R A- PI T A, f or 
w hic h  i nf or mati o n  re q uire d  b y t he  st u d y  will  be  rec or de d  i n  case  re p ort  f or ms  ( C R Fs) 
base d  o n  patie nt  data  prese nte d  i n  me dical  rec or ds  s uc h  as  me di cal  c harts  o btai ne d  i n 
r o uti ne me dical practice. 
8. 2.  Setti n g 
8. 2. 1.  Re gistr ati o n criteri a 
Patie nts m ust meet all of t he f oll o wi n g i ncl usi o n criteria t o b e eli gi ble f or i ncl usi o n i n t he 
st u d y :  
•  Patie nts wit h stat us e pile ptic us  w h o recei ve d L O R A- PI T A f or  t he first ti me after t he 
date w he n t his dr u g was la u nc he d. 
T he i n dicati o n, a n d d osa ge a n d a d mi nistrati o n of L O R A- PI T A are as me nti o ne d bel o w. 
Refer t o t he latest pac ka ge i n sert of t his dr u g w he n L O R A- PI T A is a d mi nistere d. 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 2 of 3 7  
[I n dicati o n(s)] Status e pile ptic us 
[ D osa ge  a n d  A d mi nistrati o n]  T he  us ual  d osa ge  of  l oraze pa m  i n  a dults  is  4  m g 
a d mi nistere d i ntra ve n o usl y. T he dr u g s h o ul d be gi ve n sl o wl y wit h t he a d mi nistrati o n rate
at 2 m g/ mi n as a g ui de. If neces sar y, 4 m g ma y be a d de d b ut t he d ose s h o ul d n ot e xcee d 8
m g as t he s u m of i niti al a n d a d diti o nal d oses. 
T he us ual d osa ge of l oraze pa m i n c hil dre n a ge d 3 m o nt hs or ol de r is 0. 0 5 m g/ k g ( u p t o 4
m g) a d mi nistere d i ntra ve n o usl y. T he dr u g s h o ul d be gi ve n sl o wl y wit h t he a d mi nistrati o n
rate at 2 m g/ mi n as a g ui de. If necessar y, 0. 0 5 m g/ k g ma y be a dde d b ut t he d ose s h o ul d 
n ot e xcee d 0. 1 m g/ k g as t he s u m of i nitial a n d a d diti o nal d oses . 
 
8. 2. 2.  E xcl usi o n criteri a 
N ot s pecifie d i n t his st u d y.  
8. 2. 3.  St u d y sites 
T his  st u d y  will  be  i m ple me nte d  at  a p pr o xi matel y  4 0  sites  i n  t ot al  i ncl u di n g  t he 
De part me nt  of  Ne ur ol o gical  S ur ger y,  De part me nt  of  Ne ur ol o g y  a n d   E mer ge nc y  R o o m 
w here e mer ge nc y treat me nt is a v aila ble a n d L O R A- PI T A is deli ver e d. 
8. 2. 4.  Pl a n ne d st u d y peri o d 
T he pla n ne d peri o d of t hi s st u d y is as f oll o ws: 
I n vesti gati o n peri o d: 0 1 Marc h 2 0 1 9 t o 0 2 J u ne 2 0 2 3 
( T he  i n vesti gati o n  peri o d  will  be  fr o m  t he  start  of  re gistrati on  t o  t he  c o m pleti o n  of  t he 
o bser vati o n peri o d of t he las t patie nt re gistere d.) 
Re gistrati o n peri o d:  0 1 Marc h 2 0 1 9 t o 3 1 Ma y 2 0 2 3 
( T he  re gistrati o n  peri o d  will  be  a  peri o d  w he n  t he  first  d ose  of  L O R A- PI T A  is  gi ve n. 
Re gistrati o n  will  be  ter mi nate d  pri or  t o  t he  c o m pleti o n  of  t he re gistrati o n  peri o d  if  t he 
tar get n u m ber of patie nts is reac he d.) 
8. 2. 5.  St u d y pr oce d ures 
8. 2. 5. 1.  St u d y met h o d 
Fi xe d- p oi nt  all  patie nts  s ur vei lla nce  s yste m:  T his  st u d y  will  be  c o n d ucte d  wit h  fi xe d-
p oi nt  all  patie nts  s ur veilla nce  s yste m  t o  e nr oll  all  patie nts  w h o  use d  L O R A- PI T A  at 
s pecifie d  c o ntract  sites  ( pla n ne d  t o  be  a p pr o xi matel y  4 0  sites)  after  t he  c o ncl usi o n  of 
c o ntracts a n d w h o meet t he re gis trati o n criteria ( 8. 2. 1.) f or this st u d y at t he sai d sites. 
8. 2. 6.  O bser v ati o n peri o d 
T h e o bs er v ati o n p eri o d will b e fr o m t h e first d os e of L O R A- PI T A  t o 2 4 h o urs after t he 
e n d of t he last d ose. A f oll o w- u p peri o d will be 2 4 h o urs after  t he e n d of t he last d ose, 
a n d  if  t he  f oll o w- u p  peri o d  is  less  t ha n  2 4  h o urs,  s uc h  patie nt s  will  be  dee me d  as 
wit h dra wals. 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 3 of 3 7  
T he  i n vesti gat or  s hall  ma ke  a n  i n q uir y  o n  wit h dra wals  t o  t he  pa tie nts  or  t heir  fa milies 
later  t ha n  2 4  h o urs  after  t he  en d  of  t he  last  d ose  b y  tele p h o ne   or  usi n g  ot her  rele va nt 
mea ns t o t he e xte nt p ossi ble. A fter o btai ni n g safet y i nf or mati on u p t o 2 4 h o urs after t he 
e n d of t he last d ose, t he i n vesti g at or s hall e val uate a d verse e ve nts ( A Es) a n d i n p ut data. 
8. 3.  V ari a bles 
T his st u d y will be c o n d ucte d acc or di n g t o t he f oll o wi n g sc he d ul e of o bser vati o n ( Ta ble 1). 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 4 of 3 7  
T a ble 1.  
V ari a bles a n d sc he d ule of o bser v ati o n 
Ti mi n g 
 
 
V ari a bles 
At t h e ti m e 
of 
r e gist r ati o n 
( Re gistr ati o n 
f or m) 
− 
O bser v ati o n peri o d 
C ase re p ort f or m 
Bef ore t h e st art of 
L O R A- PI T A 
a d mi nistr ati o n or 
at t he first d ose
After t he first 
d ose 
After a n 
a d diti o n al 
d ose (if 
a p plic a ble) 
After t he e n d 
of t he l ast 
d ose t o 2 4 
h o urs 
( F oll o w- u p 
peri o d) 
B a c k gr o u n d 
I D n u m ber 
 
() * 
 
 
 
Ge n der 
 
() * 
 
 
 
Birt h year a n d m o nt h / a ge 
 
() * 
 
 
 
Da y of t he first d ose of L O R A- PI T A
 
() * 
 
 
 
P ositi o ni n g of L O R A- PI T A f or t he 
tar get disease
 
() * 
 
 
 
Eli gi bilit y 
 
 
 
 
 
B o d y wei g ht 
 
 
 
 
 
I n p ati e nt/ o ut p ati e nt st at us 
 
 
 
 
 
Hist or y of dri n ki n g 
 
 
 
 
 
Disease hist or y (i n cl u di n g 
i de ntificati o n of t he ca usati ve 
disease a n d treat me nt-resista nt 
disease) 
 
 
 
 
 
Prese nce/a bse nce of li ver f u ncti o nal 
i m pair me nt a n d re nal f u ncti o nal 
i m pair me nt 
 
 
 
 
 
I nf or mati o n o n 
t he tar get 
disease (stat us 
e pile ptic us) 
Seiz ure t y pe 
classificati o n 
 
 
 
 
 
Date a n d ti me of 
o nse t 
 
 
 
 
 
Seiz ure s y m pt o m 
 
 
 
 
 
A ge w he n t he first e pile ptic e pis o de 
occ urre d 
 
 
 
 
 
Prese nce/a bse nce of treat me nt wit h 
dr u gs affecti n g gl uc ur o ni dati o n  
meta b olis m 
 
 
 
 
 
Reas o n f or usi n g L O R A- PI T A 
 
 
 
 
 
Pr e g n a n c y st at us ( w o m e n o nl y) 
 
 
 
 
 
Tests 
Bl o o d press ure, p ulse rate  
 
 
 
 
 
O x y ge n sat urati o n b y p ulse o xi metr y 
 
 
 
 
 
La b orat or y tests 
( Bl o o d gl uc ose/ he mat ol o g y) 
 
 
 
 
 
L O R A- PI T A a d mi nistrati o n rec or d 
 ( per a d mi nistrati o n) 
 
 
 
() 
 
C o nc o mita nt t hera p y ( Dr u g t hera p y/ N o n- dr u g 
t hera p y) 
 
 
 
 
 
Effi c a c y 
e v al u ati o n 
Date a n d ti me of t he res ol uti o n of 
seiz ure 
 
 
 
 
 
I nf or mati o n o n re c urre nt seiz ure 
( o nl y w he n a p plica ble) 
 
 
 
 
()  
() 
A d verse e ve nts * * 
 
 
 
 
 
S u m mar y of t he patie nt 
 
 
 
 
 
* S o me ele me nts i n t he re gistra ti o n f or m are a ut o maticall y reflecte d i n t h e C R F. 
* * A d verse e ve nts: W he n t he f oll o w- u p peri o d is less t ha n 2 4 h o urs, t he i n vesti gat or s hall ma ke a n i n q uir y t o t he patie nts or t heir 
fa milies b y tele p h o ne or usi n g other rele va nt mea ns t o t he e xte nt p ossi ble t o assess safet y u p t o 2 4 h o urs after t h e e n d of t h e last d ose. 
8. 3. 1.  P atie nt c h ar acteristics 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 5 of 3 7  
E nter  t he  i nf or mati o n  at  t he  start  of  a d mi nistrati o n  of  L O R A- PI T A  i n  t he  re gistrati o n 
f or m1 (I nf or mati o n i n p ut i n t he re gistrati o n f or m ot her t ha n “eli gi bilit y” is a ut o maticall y 
reflecte d i n t he C R F.) 
•  I D n u m ber 
•  Ge n der 
•  Birt h year a n d m o nt h 
•  Da y of t he first d os e of L O R A- PI T A 
•  P ositi o ni n g of L O R A- PI T A f or t he tar get disease ( w het her or n ot  t his dr u g is t he first 
dr u g a d mi nistere d) 
•  Eli gi bilit y 
I n p ut t he f oll o wi n g i nf or mati o n pri or t o t he start of a d mi nistr ati o n of L O R A- PI T A i n t he 
C R F 2: 
•  B o d y wei g ht 
If b o d y wei g ht data pri or t o t he start of a d mi nistrati o n are a vaila ble, e nter t he b o d y 
wei g ht meas ure d o n a da y nearest t o t he da y of a d mi nistrati o n. F or c hil dre n, rec or d 
b o d y wei g ht e q ui vale nt t o t he d ose. 
•  I n patie nt/ o ut patie nt stat us 
•  Hist or y of dri n ki n g ( wit hi n 2 4 h o urs  pri or t o t he start of a d ministrati o n) 
•  Disease hist or y ( past hist or y a n d c o nc urre nt ill ness) 
A disease b y w hic h a patie nt ha d bee n affecte d pri or t o L O R A- PI T A a d mi nistrati o n 
b ut c ure d at t he ti me of L O R A- PI T A a d mi nistrati o n is dee me d as “ past hist or y,” a n d 
a disease b y w hic h a patie nt is affecte d at t he ti me of L O R A- PI T A a d mi nistrati o n is 
“c o nc urre nt ill ness.” 
F or  eac h  disease  hist or y,  e nter  w het her  or  n ot  a  disease  is  li k el y  t o  be  t he  ca use  of 
stat us e pile ptic us or s u g gests treat me nt resista nce. 
•  Prese nce/a bse nce of li ver f u ncti o nal i m pair me nt a n d re nal f u nct i o nal i m pair me nt 
Li ver  f u ncti o nal  i m pair me nt  a n d  re nal  f u ncti o nal  i m pair me nt  are   n ot  tra nsie nt 
la b orat or y  a b n or malities  b ut  refer  t o  a n  e ve nt  t hat  s h o ul d  be  cli nicall y  n ote d  a n d 
re q uires t he f oll o w- u p. 
•  Reas o n f or usi n g L O R A- PI T A 
•  Seiz ure s u bject t o treat me nt wit h L O R A- PI T A a n d seiz ure t y pe cl assificati o n 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 6 of 3 7  
T he t y pe of a seiz ure s u bject t o L O R A- PI T A treat me nt s h o ul d be classifie d usi n g t he 
“ E pile ptic  Seiz ure  T y pe  Classificati o n”  ( Ta ble 2)  p u blis he d  i n 1 9 8 1  b y  t he 
I nter nati o nal Lea g ue A gai nst E pile ps y (I L A E). 
•  Seiz ure  s u bject  t o  treat me nt  wit h  L O R A- PI T A:  Seiz ure  s y m pt o m  (s tat us 
e pile ptic us/re petiti ve stat us e pile ptic us) 
•  Seiz ure s u bject t o treat me nt wit h L O R A- PI T A: Ti me a n d date of o nset 
•  A ge w he n t he first e pile ptic e pis o de occ urre d 
•  Prese nce/a bse nce of treat me nt wit h dr u gs ( pr o be neci d a n d oral c o ntrace pti ve ster oi d) 
affecti n g gl uc ur o ni dati o n meta b olis m 
•  Pr e g n a n c y st at us ( w o m e n o nl y) 
T a ble 2.  
E pile ptic Seiz ure T y pe  Cl assific ati o n (I L A E, 1 9 8 1 versi o n) 
P arti al seiz ures 
Ge ner alize d seiz ures 
A. Si m ple partial sei z ures (c o nsci o us ness 
n ot i m paire d) 
1.  Wit h m ot or si g ns 
2.  Wit h s o mat ose ns or y or s pecial 
se ns or y s y m pt o ms 
3.  Wit h a ut o n o mic s y m pt o ms or si g ns 
4.  Wit h ps yc hic s y m pt o ms ( Ma n y of 
t he m are e x perie nce d as “c o m ple x 
partial seiz ures.”) 
A. 1. A bse nce seiz ures 
a. i m pair me nt of c o nsci o us ness o nl y 
b.  wit h mil d cl o nic c o m p o ne nts 
c. wit h at o nic c o m p o ne nts 
d.  wit h t o nic c o m p o ne nts 
e. wit h a ut o matis ms 
f. wit h a ut o n o mic c o m p o ne nts 
( b t hr o u g h f ma y be use d al o ne or i n 
c o m bi nati o n) 
2. At y pical a bse nce seiz ures 
a. c ha n ges i n t o ne t hat are m ore 
pr o n o u nce d t ha n i n A. 1. 
b.  o nset a n d/ or offset t hat is n ot 
a br u pt 
B. C o m ple x partial seiz ures  
1.  Si m ple partial o nset f oll o we d b y 
i m pair me nt of c o nsci o us ness 
a. si m ple partial o nset  
b.  m ot or o nset 
2.  Wit h i m pair me nt of c o nsci o us ness at 
o nset 
B. M y ocl o nic seiz ures 
C. Partial seiz ures e v ol vi n g t o sec o n daril y 
ge neralize d seiz ures 
C. Cl o nic seiz ures 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 7 of 3 7  
D. T o nic seiz ures 
E. T o nic-cl o nic seiz ures 
F. At o nic seiz ures 
U nclassifie d e pile ptic seiz u res 
Ne o natal seiz ures    r h y t h mic ey e m o ve me nts    c he wi n g    s wi m mi ng  m o ve me nts 
 
8. 3. 2.  A d mi nistr ati o n of t ar gete d dr u g 
T he  f oll o wi n g  i nf or mati o n  will  be   rec or de d  per  a d mi nistrati o n  for  t he  stat us  of  L O R A-
PI T A treat me nt:  
•  D ose 
•  Ti me a n d date of t he sta rt of a d mi nistrati o n 
•  Ti me a n d date of t he e n d of a d mi nistrati o n 
8. 3. 3.  Dr u g t her a p y ( pre me dic ati o n a n d c o nc o mit a nt me dic ati o ns) 
8. 3. 3. 1.  Dr u gs f or t he tre at me nt of st at us e pile ptic us 
T he prese nce or a bse nce of t he  use of dr u gs c orres p o n di n g t o t he f oll o wi n g ite ms d uri n g a 
peri o d fr o m 2 4 h o urs bef ore t he sta rt of L O R A- PI T A a d mi nistratio n t o t he c o m pleti o n of 
t he o bser vati o n peri o d s h o ul d be e ntere d. If “ prese nt,” t he na mes of dr u gs use d a n d t heir 
details  ( d ose,  ti me  a n d  date  of t he  start  of  a d mi nistrati o n,  time  a n d  date  of  t he  e n d  of 
a d mi nistrati o n, a n d reas o n f or a d mi nistrati o n) s h o ul d be rec or d e d. 
•  Diaze pa m i njecti o n 
•  Mi daz ola m i njecti o n 
•  P he n o bar bital i njecti o n 
•  P he n yt oi n i njecti o n 
•  F os p he n yt oi n i njecti o n 
•  Le vetiraceta m i njecti o n 
•  T hi o pe ntal i njecti o n 
•  Pr o p of ol i njecti o n 
•  T hia m ylal i njecti o n 
•  Diaze pa m s u p p osit ories 
•  C hl oral h y drate s u p p osit ories 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 8 of 3 7  
•  P he n o bar bital s u p p osit ories 
•  Ot hers 
8. 3. 3. 2.  Or al a ntie pile ptic dr u gs 
T he prese nce or a bse nce of oral a ntie pile ptic dr u gs use d i n c o m bi nati o n d uri n g a peri o d 
fr o m  2 4  h o urs  bef ore  t he  start  of  L O R A- PI T A  a d mi nistrati o n  t o  the  c o m pleti o n  of  t he 
o bser vati o n peri o d s h o ul d be e nter e d. If “ prese nt,” t he na mes o f s pecific dr u gs use d, a n d 
ti me a n d date of a d mi nistrati o n s h o ul d be rec or de d. 
8. 3. 3. 3.  Dr u gs affecti n g t he i n hi biti o n of t he ce ntr al ner v o us s yste m (e . g., a nest hetics, 
a nti de press a nts, a n xi ol ytics a n d h y p n otics) 
T he prese nce or a bse nce of t he use of dr u gs affecti n g t he i n hi biti o n of t he ce ntral ner v o us 
s yste m d uri n g a peri o d fr o m 2 4 h ours bef ore t he start of L O R A- P I T A a d mi nistrati o n t o 
t he  c o m pleti o n  of  t he  o bser vatio n  peri o d  s h o ul d  be  e ntere d.  If “ prese nt,”  t he  na mes  of 
s pecific dr u gs use d a n d t heir details (r o ute of a d mi nistrati o n, ti me a n d date of t he start of 
a d mi nistrati o n, a n d ti me a n d date o f t he e n d of a dmi nistrati o n)  s h o ul d be rec or de d. 
8. 3. 3. 4.  Ot her c o nc o mit a nt me dic ati o ns ( T o be c ollecte d o nl y f or p atie nts wit h A Es) 
If  a n  A E  occ urre d  after  t he  start  of  L O R A- PI T A  a d mi nistrati o n, t he  na mes  of  s pecific 
dr u gs use d f or t he treat me nt of  t he A E s h o ul d als o be d oc u me nted. 
8. 3. 4.  N o n- dr u g t her a p y ( T o be c ollect e d o nl y f or p atie nts wit h A Es) 
If  a n  A E  occ urre d  after  t he  start  of  L O R A- PI T A  a d mi nistrati o n, t he  na mes  of  s pecific 
n o n- dr u g t hera pies use d f or t he t reat me nt of t he A E s h o ul d als o be rec or de d. 
8. 3. 5.  Tests/cli nic al l a b or at or y tests 
T he  res ults  of  t he  f oll o wi n g  tests  perf or me d  fr o m  baseli ne  (i nc l u di n g  t he  start  ti me  of 
a d mi nistrati o n)  t o  t he  c o m pleti o n  of  t he  o bser vati o n  peri o d  s h o ul d  be  rec or de d.  A n 
a b n or mal c ha n ge i n a la b orat or y val ue s h o ul d als o be d oc u me nte d  i n detail i n t he a d verse 
e ve nt fiel d, if it is cli nicall y si g nifica nt c o m pare d t o t he ba seli ne val ue. 
8. 3. 5. 1.  Vit al si g ns 
•  Bl o o d press ure (s yst olic a n d diast olic) 
•  P ulse rate 
•  O x y ge n sat urati o n b y p ulse o xi metr y ( S p O 2) 
8. 3. 5. 2.  Cli nic al l a b or at or y tests 
•  Bl o o d gl uc ose 
•  He mat ol o g y  ( w hite  bl o o d  cell  c o u nt,  re d  bl o o d  cell  c o u nt,  ne utr o p hils,  e osi n o p hils, 
bas o p hils, m o n oc ytes, l y m p h oc ytes a n d platelet c o u nt) 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 1 9 of 3 7  
8. 3. 6.  E n d- of-st u d y ( Disc o nti n u ati o n) rec or d ( S u m m ar y of t he p atie nt i ncl u di n g 
Re as o n f or disc o nti n u ati o n) 
E nter  t he  ti me  a n d  date  of  t he  c o m pleti o n  of  t he  o bser vati o n  peri o d.  If  t he  f oll o w- u p 
peri o d after t he last a d mi nistrati o n of L O R A- PI T A is less t ha n 2 4 h o urs, select a n d rec or d 
o nl y  o ne  of  t he  f oll o wi n g  ite ms  t hat  c orres p o n ds  t o  t he  pri mar y   reas o n.  If  t he  A E  is 
c h ose n, i nf or mati o n s h o ul d be als o d oc u me nte d i n t he a d verse e v e nt fiel d: 
•  C o m plete d 
•  A E 
•  Deat h 
•  L ost t o f oll o w- u p 
•  Ot her 
8. 3. 7.  E v al u ati o n of st at us e pile ptic u s seiz ure (effic ac y e v al u ati o n) 
8. 3. 7. 1.  Ti me a n d d ate of res ol uti o n of seiz ure 
E nter  t he  ti me  a n d  date  of  t he  r es ol uti o n  of  seiz ure  treate d  wi t h  L O R A- PI T A.  T he 
res ol uti o n of seiz ure s h o ul d be deter mi ne d usi n g t he sa me criteria ( vis ual i ns pecti o n a n d 
electr oe nce p hal o gra p h y) as t h ose f or t he o nset of seiz ure. 
8. 3. 7. 2.  Ti me a n d d ate of rec urre nt seiz ure a n d ti me of res ol uti o n 
If a seiz ure treate d wit h L O R A- PI T A res ol ve d o nce a n d t he n rec urre d (rec urre nt seiz ure) 
d uri n g  t he  o bser vati o n  peri o d,  a seiz ure  s y m pt o m  (stat us  e pile ptic us,  re petiti ve  stat us 
e pile ptic us or ot hers), t he ti me a n d date of seiz ure occ urre d, a n d t he ti me a n d date of its 
res ol uti o n s h o ul d be rec or de d f or all rec urre nt seizers. 
8. 3. 8.  A d verse e ve nts 
T he occ urre nce of A Es fr o m t he start of L O R A- PI T A a d mi nistrati o n t o t he c o m pleti o n of 
t he  o bser vati o n  peri o d  s h o ul d  be  c o nfir me d,  a n d  t he  f oll o wi n g  i nf or mati o n  s h o ul d  be 
rec or de d. 
Als o,  f urt her  i n vesti gati o n  s h o ul d  be  se paratel y  c o n d ucte d,  if dee me d  necessar y  b y  t he 
S p o ns or f or patie nts w h o e x perie nce d a seri o us a d verse reacti o n , a n u ne x pecte d a d verse 
reacti o n or ot her a d verse reactio ns n ot liste d i n t he pac ka ge i nsert. 
•  Prese nce/a bse nce of A E 
•  Na me of A E 
•  Ti me a n d date of o nset 
•  Ti me a n d date of res ol uti o n 
•  I nter ve nti o n ( prese nce/a bse nce of a d ose c ha n ge a n d t he details of treat me nt) 
•  Seri o us ness 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 0 of 3 7  
•  O utc o me at t he e n d of o bser vati o n peri o d a n d t he  date of o utc o me c o nfir me d 
•  Ca usal relati o ns hi p t o L O R A- PI T A  
If  t he  A E  is  ass ociate d  wit h  a n a b n or mal  c ha n ge  i n  cli nical  la b orat or y  val ues,  t he 
f oll o wi n g i nf or mati o n s ho ul d als o be rec or de d: 
•  Na me of la b orat or y test 
•  Site refere nce val ue 
•  U nit 
•  Ti me a n d date of meas ure me nt 
•  Test res ults 
8. 4.  D at a s o urces 
I n  t his  st u d y,  t he  i n vesti gat ors  tra nscri be  t he  necessar y  i nf ormati o n  fr o m  t he  me dical 
rec or d u n der dail y me dical practice i n acc or da nce wit h t he pr otoc ol. 
8. 5.  St u d y size 
8. 5. 1.  Pl a n ne d s a m ple size 
T he tar get sa m ple size is 1 2 0 patie nts w h o use d L O R A- PI T A as a first-li ne dr u g ( L O R A-
PI T A is t he first dr u g utilize d f or t he tar get disease.). H o we v er, t he ma xi m u m n u m ber of 
patie nts t o be e nr olle d i n t he st u d y is 2 0 0. 
8. 5. 2.  R ati o n ale f or s a m ple size 
Gi ve n t hat t he efficac y rate f or L O R A- PI T A is 5 5 t o 8 0 %, if 1 2 0  patie nts use d t his dr u g 
as t he first-li ne treat me nt, b ot h u p per a n d l o wer li mits of a n esti mate d c o nfi de nce i nter val 
are  a p pr o xi matel y  1 0 %  fr o m  t he  mea n  val ue.  T he  statistical  acc u rac y  is  c o nsi dere d 
s ufficie nt  t o  e val uate  t he  efficac y  of  L O R A- PI T A.  I n  t his  Ge neral  I n vesti gati o n,  it  is 
ass u me d t hat t he pr o p orti o n of patie nts use d l oraze pa m as t he f irst-li ne treat me nt is a b o ut 
6 0 % i n t he re gistere d patie nts, c o nsi deri n g Ke y O pi ni o n Lea der’ s c o m me nts. H o we ver, if 
t he  act ual  n u m ber  of  patie nts  use d  l oraze pa m  as  t he  first-li ne treat me nt  is  s mall,  e ve n 
w he n 2 0 0 patie nts (esta blis he d base d o n feasi bilit y of t he st u d y) are re gistere d, it is als o 
ass u me d  t hat  fe wer  t ha n  1 2 0  patie nts  use d  l oraze pa m  as  t he  firs t-li ne  dr u g.  H o we ver, 
e ve n  ass u mi n g  t hat  t he  pr o p orti o n of  patie nts  w h o  use d  l oraze pa m as t he first-li ne 
treat me nt is e xtre mel y l o w at 3 0 % ( 6 0 patie nts), if t he efficacy rate of L O R A- PI T A is 5 5 
t o  8 0 %,  t he  t w o  si des  of  t he  c o nfi de nce  i nter val  wi dt h  val ue  are  a b o ut  1 5 %  fr o m  t he 
a vera ge val ue a n d it is p ossi ble t o c o nsi der t he efficac y of t his dr u g ( Ta ble 3). 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 1 of 3 7  
T a ble 3.  
Cl o p per- Pe ars o n t w o-si de d 9 5 % c o nfi de nce i nter v al ( N = 1 2 0 or 6 0) 
N u m ber of 
p atie nts  
( N) 
Ass u m pti o n of effic ac y 
( Pr o p orti o n of effic ac y/ P atie nts w h o 
use d l or aze p a m as t he first li ne 
tre at me nt) 
9 5 % c o nfi de nce i nter v al 
 
1 2 0 
5 5 % ( 6 6/ 1 2 0)
4 5. 7 % - 6 4. 1 % 
 
6 0 % ( 7 2/ 1 2 0)
5 0. 7 % - 6 8. 8 % 
  
6 5 % ( 7 8/ 1 2 0) 
5 5. 8 % - 7 3. 5 % 
  
7 0 % ( 8 4/ 1 2 0) 
6 1. 0 % - 7 8. 0 % 
  
7 5 % ( 9 0/ 1 2 0) 
6 6. 3 % - 8 2. 5 % 
  
8 0 % ( 9 6/ 1 2 0) 
7 1. 7 % - 8 6. 7 % 
6 0  
5 5 % ( 3 3/ 6 0) 
4 1. 6 % - 6 7. 9 % 
 
6 0 % ( 3 6/ 6 0)
4 6. 5 % - 7 2. 4 % 
  
6 5 % ( 3 9/ 6 0) 
5 1. 6 % - 7 6. 9 % 
  
7 0 % ( 4 2/ 6 0) 
5 6. 8 % - 8 1. 2 % 
  
7 5 % ( 4 5/ 6 0) 
6 2. 1 % - 8 5. 3 % 
  
8 0 % ( 4 8/ 6 0) 
6 7. 7 % - 8 9. 2 % 
 
8. 6.  D at a m a n a ge me nt 
8. 6. 1.  C ase re p ort f or ms ( C R Fs)/ Electr o nic d at a rec or d 
As use d i n t his pr ot oc ol, t he ter m C R F s h o ul d be u n derst o o d t o refer t o a n electr o nic data 
rec or d de pe n di n g o n t he data c ollecti o n met h o d use d i n t his st u d y.  
A  C R F  is  re q uire d  a n d  s h o ul d  be  c o m plete d  f or  eac h  i ncl u de d  pat ie nt.  T he  c o m plete d 
ori gi nal  C R Fs  are  t he  s ole  pr o pert y  of  Pfizer  a n d  s h o ul d  n ot  be   ma de  a vaila ble  i n  a n y 
f or m  t o  t hir d  parties,  e xce pt  f or  a ut h orize d  re prese ntati ves  of Pfizer or a p pr o priate 
re g ulat or y a ut h orities, wit h o ut writte n per missi o n fr o m Pfizer. 
T he  i n vesti gat or  s hall  e ns ure  t hat  t he  C R Fs  are  sec urel y  st ore d   at  t he  st u d y  site  i n 
e ncr y pte d electr o nic f or m a n d will be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o 
pre ve nt access b y u na ut h orize d t hir d parties. 
T he i n vesti gat or has ulti mate res p o nsi bilit y f or t he c ollecti o n  a n d re p orti n g of all cli nical, 
safet y,  a n d  la b orat or y  data  e ntere d  o n  t he  C R Fs  a n d  a n y  ot her  d ata  c ollecti o n  f or ms 
(s o urce  d oc u me nts)  a n d  e ns uri n g  t hat  t he y  are  acc urate,  a ut he ntic/ ori gi nal,  attri b uta ble, 
c o m plete,  c o nsiste nt,  le gi ble,   ti mel y  (c o nte m p ora ne o us),  e n d urin g,  a n d  a vaila ble  w he n 
re q uire d. T he C R Fs m ust be si g ne d b y t he i n vesti gat or or b y a n a ut h orize d staff me m ber 
t o attest t hat t he data c o ntai ne d o n t he C R Fs are tr ue. A n y c orrecti o ns t o e ntries ma de i n 
t he C R Fs or s o urce d oc u me nts m ust be date d, i nitiale d, a n d e x plai ne d (if necessar y) a n d 
s h o ul d n ot o bsc ure t he ori gi nal e ntr y. 
T he  s o urce  d oc u me nts  are  t he  h os pital  or  t he  p h ysicia n’s  c hart.   I n  t hese  cases,  data 
c ollecte d o n t he C R Fs m ust matc h t h ose c harts. 
8. 6. 2.  Rec or d h ol di n g 
T he rec or ds relate d t o t his st u d y s h o ul d be retai n e d at t he st u d y site u ntil t he E n d of St u d y 
Letter b y Pfizer is recei ve d or d uri n g t he peri o d defi ne d b y t h e st u d y site, w hic he ver is 
l o n ger. 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 2 of 3 7  
8. 6. 3.  D at a c ollecti o n met h o d ( E D C) 
T he data f or t his st u d y will be e ntere d i n t he C R F a n d c o nfir me d b y usi n g t he electr o nic 
s yste m  o n  t he  i nter net  desi g ne d  f or  c ollecti n g  p ost- mar keti n g  sur ve y  data  ( Electr o nic 
Data Ca pt ure, E D C; herei nafter referre d t o as t he E D C s yste m). 
8. 6. 4.  P atie nt re gistr ati o n ( E D C) 
T he  i n vesti gat or  will  e nter  re gistrati o n  ite ms  o n  t he  re gistrat i o n  scree n  of  E D C  s yste m 
a n d sa ve t he data. Patie nt re gistrati o n will be perf or me d i m me diatel y after t he first d ose 
of L O R A- PI T A is gi ve n t o a patie nt meeti n g t he re gistrati o n cri teria. If i nf or mati o n i n t he 
re gistrati o n  f or m  re q uires  c o nfir mati o n,  t he  i n vesti gat or  ma y  be  re q ueste d  t o  perf or m 
f oll o w- u p s ur ve y a n d res p o n d t o t he q uer y. Re gistrati o n will be fi xe d after t he q uer y is 
res ol ve d. 
8. 6. 5.  P oi nts t o c o nsi der f or c o m pleti o n, re visi o n, a n d s u b missi o n of c ase re p ort f or m 
( E D C) 
8. 6. 5. 1.  D at a e ntr y 
T he i n vesti gat or s h o ul d c o nfir m t h e s ur ve y ite ms, a n d e nter a n d  sa ve t he data i nt o E D C 
s yste m base d o n i nf or mati o n prese nte d i n me dical c harts. 
8. 6. 5. 2.  D at a re visi o n 
If e ntr y o missi o n or inc o nsiste nt data are i de ntifie d after sa v i n g t he data or u p o n recei vi n g 
q uer y fr o m S p o ns or o n t he c o nte nts of t he C R F, t he i n vesti gat or  will a gai n c o nfir m t he 
c o nte nts of me dical rec or ds, a n d as re q uire d, c orrect rele va nt secti o ns a n d sa ve t he data. 
8. 6. 5. 3.  S u b missi o n 
After all data e ntr y a n d re visi o n are c o m plete d, C R Fs s h o ul d be  si g ne d electr o nicall y b y 
t he  i n vesti gat or  i n  acc or da nce  wit h  pr oce d ures  s pecifie d  b y  t he  S p o ns or  f oll o wi n g  re-
c o nfir mati o n of i nf or mati o n e ntere d i n t he C R Fs. 
8. 6. 6.  Fi xe d- p oi nt all p atie nts re gistr ati o n 
1.  T he i n vesti gat ors at c o ntract s ites will re g ularl y c o nfir m t hat all patie nts w h o ha d 
bee n a d mi nistere d L O R A- PI T A ha ve  bee n re gistere d, affi x t heir si g nat ure or na me 
a n d seal t o t he “ All Patie nts S u r veilla nce C o nfir mati o n F or m,” a n d s u b mit t he f or m 
t o t he site m o nit or. T he f or m ma y be se nt b y e- mail or ot her mea ns.  
2.  I n t he e ve nt of disc o ver y of an u nre gistere d patie nt, t he re gis trati o n of t he 
c orres p o n di n g patie nt s h o ul d ta ke place pr o m ptl y.  
8. 7.  D at a a n al ysis 
Detaile d met h o d ol o g y f or s u m mar y a n d statistical a nal yses of da ta c ollecte d i n t his st u d y 
will be d oc u me nte d i n a Statistical A nal ysis Pla n ( S A P), w hic h will be date d, file d a n d 
mai ntai ne d b y t he s p o ns or. T he S A P ma y m o dif y t he pla ns o utli ne d i n t he pr ot oc ol; a n y 
maj or m o dificati o ns of pri mar y e n d p oi nt defi niti o ns or t heir a n al yses w o ul d be reflecte d 
i n a pr ot oc ol a me n d me nt. 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 3 of 3 7  
8. 7. 1.  A n al ysis f or s afet y e v al u ati o n 
T he  safet y  a nal ysis  set  ( S A S)  c o nsists  of  a  f ull  a nal ysis  set  ( F A S)  t hat  is  as  cl oser  as 
p ossi ble t o all patie nts w h o recei ve d L O R A- PI T A. 
I n t he S A S, t he occ urre nce a n d i nci de nce ( pr o p orti o n of patie nt s wit h A Es) of A Es d uri n g 
t he o bser vati o n peri o d will be e val uate d. Als o, e x pl orat or y a nal yses will be, as necessar y, 
perf or me d s uc h as e val uati o n of fact ors affecti n g safet y. 
8. 7. 2.  A n al ysis f or effic ac y e v al u ati o n 
T w o  efficac y  a nal ysis  sets  will  be  s pecifie d:  a  p o p ulati o n  of  p atie nts  e val ua ble  f or 
efficac y w h o use d L O R A- PI T A as t he first-li ne dr u g a n d a p o p ula ti o n of patie nts w h o are 
e val ua ble f or efficac y. 
I n t he a b o ve me nti o ne d a nal ysis sets, t he f oll o wi n g a nal yses will be carrie d o ut t o assess 
t he  efficac y  of  L O R A- PI T A  u n der  act ual  use  c o n diti o ns  i n  reference  t o  Trei ma n  D M’s 
pa per  a n d  t he  res ults  fr o m  P E C A R N  st u d y  a n d  a  Ja pa nese  P hase  3  st u d y  ( B 3 5 4 1 0 0 2) 
a m o n g f o ur st u dies (i ncl u di n g R A M P A R T st u d y a n d P E C A R N st u d y) c orres p o n di n g t o 
Class  I  acc or di n g  t o  t he  A merica n  E pile ps y  S ociet y  ( A E S)  g ui del i nes  ( 2 0 1 6)  a n d  t he 
Ja pa nese  P hase  3  st u d y  ( B 3 5 4 1 0 0 2)  liste d  i n  Ta ble  4.  I n  a d diti on,  e x pl orat or y  a nal yses 
will be, as necessar y, perf or me d s uc h as e val uati o n of fact ors affecti n g efficac y. 
•  Patie nts,  w h ose  seiz ure  res ol ve d  wit hi n  1 0  mi n utes  after  t he  fi rst  a d mi nistrati o n  of 
L O R A- PI T A  or  t he  sec o n d  a d mi nistrati o n  ( 1 0  t o  3 0  mi n utes  after 
t he  first 
a d mi nistrati o n) a n d w h o d o n ot re q uire a d diti o nal treat me nt wit h ot her dr u gs f or t he 
tar get  disease  wit hi n  3 0  mi n utes  after  t he  e n d  of  a d mi nistrati on  (e xcl u di n g 
pr o p h ylactic a d mi nistrati o n) a n d ha ve n o rec urre nt seiz ure, are  defi ne d as res p o n ders, 
a n d t heir pr o p orti o n w ill be ta b ulate d. 
•  Patie nts,  w h ose  seiz ure  res ol ve d  wit hi n  1 0  mi n utes  after  t he  fi rst  a d mi nistrati o n  of 
L O R A- PI T A  a n d  w h o  d o  n ot  re q uire  a d diti o nal  treat me nt  wit h  ot he r  dr u gs  f or  t he 
tar get  disease  wit hi n  3 0  mi n utes  after  t he  e n d  of  a d mi nistrati on  (e xcl u di n g 
pr o p h ylactic a d mi nistrati o n) a n d ha ve n o rec urre nt seiz ure, are  defi ne d as res p o n ders, 
a n d t heir pr o p orti o n w ill be ta b ulate d. 
•  Patie nts, w h ose seiz ure res ol ve d wit hi n 2 0 mi n utes after t he st art of a d mi nistrati o n of 
L O R A- PI T A  a n d  w h o  d o  n ot  re q uire  a d diti o nal  treat me nt  wit h  ot he r  dr u gs  f or  t he 
tar get  disease  wit hi n  6 0  mi n utes  after  t he  start  of  a d mi nistrati o n  (e xcl u di n g 
pr o p h ylactic a d mi nistrati o n) a n d ha ve n o rec urre nt seiz ure, are  defi ne d as res p o n ders, 
a n d t heir pr o p orti o n w ill be ta b ulate d. 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 4 of 3 7  
T a ble 4.  
Cli nic al st u dies t o be use d as refere nces w he n e x a mi ni n g t he res ults of 
t he dr u g use i n vesti g ati o n 
 
Cli nic al 
st u d y ( ye ar) 
Desi g n  
A ge 
gr o u p 
Effic ac y r ate i n 
t he l or aze p a m 
i njecti o n gr o u p
9 5 % 
c o nfi de nce 
i nter v alb  
Effic ac y criteri a 
Trei ma n 
D M 
( 1 9 9 8)3  
D o u ble- bli n d 
( L O R A- PI T A 
vs. diaze pa m/ 
p he n yt oi n 
vs. p he n yt oi n 
vs. 
p he n o bar bital) 
A d ults ( ≥ 
1 8 years 
ol d) 
6 4. 9 % 
( 6 3a/ 9 7) 
5 4. 6 % -
7 4. 4 % 
Res ol uti o n of seiz ure 
wit hi n 2 0 mi n utes after t he 
start of a d mi nistrati o n 
wit h o ut rec urre nce wit hi n 
2 0 t o 6 0 mi n utes after t he 
start of a d mi nistrati o n 
All dre d ge 
B K 
( 2 0 0 1)4  
D o u ble- bli n d 
( L O R A- PI T A 
vs. diaze pa m 
vs. place b o) 
A d ults ( ≥ 
1 8 years 
ol d) 
5 9. 1 % 
( 3 9/ 6 6) 
4 6. 3 % -
7 1. 0 % 
Res ol uti o n of seiz ure 
bef ore arri vi n g at t he 
e mer ge nc y o ut patie nt u nit 
R A M P A R T 
( 2 0 1 2)5  
D o u ble- bli n d 
( L O R A- PI T A 
vs. mi daz ola m 
i ntra m usc ular 
i njecti o n) 
A d ults 
a n d 
c hil dre n 
( 1 t o 9 4 
y ears old )
6 3. 4 % 
( 2 8 2/ 4 4 5) 
5 8. 7 % - 
6 7. 9 % 
Res ol uti o n of seiz ure n ot 
re q uiri n g a d diti o nal 
treat me nt a n d bef ore 
arri vi n g at t he e mer ge nc y 
o ut patie nt u nit 
P E C A R N 
( 2 0 1 4)6  
D o u ble- bli n d 
( L O R A- PI T A 
vs. diaze pa m) 
C hil dre n 
( 3 
m o nt hs t o 
1 8 years 
ol d) 
7 2. 9 % 
( 9 7/ 1 3 3) 
6 4. 5 % - 
8 0. 3 % 
Res ol uti o n of seiz ure 
wit hi n 1 0 mi n utes after t he 
start of a d mi nistrati o n 
wit h o ut rec urre nce wit hi n 
3 0 mi n utes after t he start of 
a d mi nistrati o n 
B 3 5 4 1 0 0 2 
(Ja pa nese 
P hase 3 
st u d y, 2 0 1 4-
2 0 1 6) 
O pe n 
O pe n-la bel, 
u nc o ntr olle d 
( L O R A- PI T A) 
A d ults 
a n d 
c hil dre n 
( 0 t o 4 9 
years ol d)
Pri mar y 
e n d p oi nt 
4 8. 0 % 
( 1 2/ 2 5) 
2 7. 8 % - 
6 8. 7 % 
Res ol uti o n of seiz ure 
wit hi n 1 0 mi n utes after t he 
e n d of first a d mi nistrati o n 
of t he i n vesti gati o nal dr u g 
wit h o ut rec urre nce wit hi n 
3 0 mi n utes after t he e n d of 
a d mi nistrati o n 
Ke y sec o n dar y 
e n d p oi nt 
6 4. 0 % 
( 1 6/ 2 5) 
4 2. 5 % - 
8 2. 0 % 
Res ol uti o n of seiz ure 
wit hi n 1 0 mi n utes after t he 
e n d of a d mi nistrati o n of t he 
i n vesti gati o nal dr u g [first 
a d mi nistrati o n or sec o n d 
a d mi nistrati o n ( 1 0 t o 3 0 
mi n utes after t he first 
a d mi nistrati o n)] wit h o ut 
rec urre nce wit hi n 3 0 
mi n utes after t he e n d of 
a d mi nistrati o n 
3: Trei ma n D M, et al. N E n gl J Me d 1 9 9 8; 3 3 9: 7 9 2- 7 9 8.  
4: All dre d ge B K, et al. N E n gl J Me d 2 0 0 1; 3 4 5: 6 3 1- 6 3 7. 
5: Sil ber gleit R, et al. N  E n gl J Me d 2 0 1 2; 3 6 6: 5 9 1- 6 0 0.  
6: C ha m berlai n J M, et al. J A M A 2 0 1 4; 3 1 1: 1 6 5 2- 1 6 6 0. 
3 - 6: C orres p o n di n g t o Class I of t he A merica n E pile ps y S ociet y ( A E S) g ui deli nes ( Gla user T, et al. E pile ps y 
C urr. 2 0 1 6; 1 6: 4 8- 6 1.) 
a: Esti mate d base d o n t he efficac y  rate a n d n u m ber of patie nts i n t he l oraze pa m i njecti o n gr o u p 
b : Calc ulate d usi ng  the Cl o p per- Pears o n met h o d base d o n t he n u m bers of res p o n ders a n d patie nts 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 5 of 3 7  
8. 8.  Q u alit y c o ntr ol 
Pri or t o c o n d ucti n g t he st u d y, t he site m o nit or will e x plai n t o  t he i n vesti gat or a b o ut t he 
c o nte nts of t he pr ot oc ol, etc.  a n d as k t he i n vesti gat or f or c o m pleti o n of C R Fs base d o n 
me dical c harts. 
 
8. 9.  Li mit ati o ns of t he  rese arc h met h o ds 
T here ma y be p ote ntial li mitati o ns i n t his st u d y: 
•  Si nce  n o  c o ntr ol  gr o u p  is  i ncl u de d  i n  t he  st u d y,  t here  is  a  li m itati o n  i n  deter mi ni n g 
w het her  or  n ot  a  ris k  of  de vel o pi n g  A Es  a n d  a d verse  reacti o ns  i ncreases  wit h 
a d mi nistrati o n of L O R A- PI T A. 
•  D ue  c o nsi derati o n  ma y  n ot  be  gi ve n  t o  c o nf o u n di n g  fact ors  d ue  t o  i ns ufficie nt 
bac k gr o u n d i nf or mati o n c ollecte d. 
•  Si nce  t his  st u d y  c ollects  t he  i nf or mati o n  descri be d  i n  me dical c harts,  s pecifie d  data 
ma y n ot be c ollecte d or ma y be missi n g. 
8. 1 0.  Ot her as pects 
N ot a p plica ble 
9.  P R O T E C TI O N O F H U M A N S U B J E C T S 
9. 1.  P atie nt I nf or m ati o n 
All  parties  will  c o m pl y  wit h  all  a p plica ble  la ws,  i ncl u di n g  la w s  re gar di n g  t he 
i m ple me ntati o n of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of patie nt 
pers o nal  data.  S uc h  meas ures  wi ll  i ncl u de  o mitti n g  patie nt  na mes  or  ot her  directl y 
i de ntifia ble data i n a n y re p orts, p u blicati o ns, or ot her discl os ures, e xce pt w here re q uire d 
b y  a p plica ble  la ws.  T he  pers o nal  data  of  t he  patie nts  will  be  s t ore d  at  t he  st u d y  site  i n 
e ncr y pte d  electr o nic  a n d/ or  pa per  f or m  a n d  will  be  pass w or d  pr otecte d  or  sec ure d  i n  a 
l oc ke d  r o o m  t o  e ns ure  t hat  o nl y a ut h orize d  st u d y  staff  ha ve  acc ess. T he st u d y site will 
i m ple me nt a p pr o priate tec h nical a nd or ga nizati o nal meas ures t o e ns ure t hat t he pers o nal 
data  ca n  be  rec o vere d  i n  t he  e ve nt  of  disaster.  I n  t he  e ve nt  of   a  p ote ntial  pers o nal  data 
breac h, t he st u d y site s hall be r es p o nsi ble f or deter mi ni n g w he t her a pers o nal data breac h 
has i n fact occ urre d a n d, if s o, pr o vi di n g breac h n otificati o ns  as re q uire d b y la w. 
 
T o pr otect t he ri g hts a n d free d o m s  of  nat ural  pers o ns  wit h  re gar d  t o  t he  pr ocessi n g  of 
pers o nal  data,  w he n  st u d y  data  are  c o m pile d  f or  tra nsfer  t o  Pfi zer  a n d  ot her  a ut h orize d 
parties,  patie nt  na mes  will  be  re m o ve d  a n d  will  be  re place d  b y a  si n gle,  s pecific, 
n u merical  c o de,  base d  o n  a  n u m beri n g  s yste m  defi ne d  b y  Pfizer. All  ot her  i de ntifia ble 
data  tra nsferre d  t o  Pfizer  or  ot h er  a ut h orize d  parties  will  be i de ntifie d  b y  t his  si n gle, 
patie nt-s pecific  c o de.  T he  st u d y  site  will  mai ntai n  a  c o nfi de nt ial  list  of  patie nts  w h o 
partici pate d  i n  t he  st u d y,  li n ki n g  eac h  patie nt’s  n u merical  c o d e  t o  his  or  her  act ual 
i de ntit y. I n case of data tra nsfer, Pfizer will mai ntai n hi g h s ta n dar ds of c o nfi de ntialit y a n d 
pr otecti o n  of  patie nts’  pers o na l  data  c o nsiste nt  wit h  t he  cli nical  st u d y  a gree me nt  a n d 
a p plica ble pri vac y la ws ( Pers o nal I nf or mati o n Pr otecti o n Act). 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 6 of 3 7  
9. 2.  P atie nt C o nse nt 
As t his st u d y d oes n ot i n v ol ve data s u bject t o pri vac y la ws acc or di n g t o a p plica ble le gal 
re q uire me nts,  or  it  is  a n  i nf or mati o n  pr o visi o n  base d  o n  t he  law  (e ve n  t h o u g h  t hat 
i n v ol ves  data  s u bject  t o  pri vac y  la ws  acc or di n g  t o  a p plica ble  le gal  re q uire me nts), 
o btai ni n g  i nf or me d  c o nse nt  fr o m  patie nts  b y  Pfizer  is  n ot  re q ui re d.  Als o,  beca use  t he 
re p ort of i nf or mati o n or res ults c ollecte d i n t his st u d y t o t he l ocal re g ulat or y a ut h orit y or 
healt hcare  pr o vi ders  b y  Pfizer  as  nee de d  is  a n  i nf or mati o n  pr o v isi o n  base d  o n  t he  la w, 
o btai ni n g i nf or me d c o nse nt fr o m  patie nts b y Pfizer is n ot re q uire d. 
I n t his st u d y, Pfizer will c ollect i nf or mati o n t hat ca n n ot i de ntif y s pecific patie nts fr o m t he 
sites. T he res ults of t his st u d y, w hic h are pre pare d n ot t o i dentif y s pecific pa tie nts, ma y be 
re p orte d t o Pfizer I nc. or gr o u p c o m pa nies, or re g ulat or y a ut h orities i n ot her c o u ntries, as 
nee de d, or p u blis he d as a prese ntati o n at aca de mic c o nfere nces or a pa per f or t he p ur p ose 
of pr o vi di n g pr o per use i nf or ma ti o n f or t his dr u g. If t his i nf or mati o n falls u n der pers o nal 
i nf or mati o n of t he Pers o nal I nf or mati o n Pr otecti o n Act, t hese acti o ns ma y n ot be base d 
o n t he la ws or re g ulati o ns, a n d t heref ore, ma y c orres p o n d t o pr o visi o n t o t he t hir d part y 
a n d usi n g t he i nf or mati o n f or p ur p oses ot her t ha n b usi ness t hat  re q uire c o nse nt fr o m t he 
patie nt. T heref ore, t he st u d y sites will o btai n writte n or ver b al c o nse nt fr o m t he patie nts 
t o  be  i ncl u de d  i n  t his  st u d y  s o  t hat  Pfizer  ca n  use  t he  res ults  of  t his  st u d y  t o  re p ort  t o 
Pfizer  I nc.,  gr o u p  c o m pa nies  or  r e g ulat or y  a ut h orities  i n  ot her   c o u ntries,  or  t o  prese nt 
t he m  at  aca de mic  c o nfere nces  or p u blis h  a  pa per,  etc.  I nf or mati o n  re gar di n g  w het her 
c o nse nt  is  o btai ne d  fr o m  patie nt s  or  n ot  is  descri be d  i n  t he  C RF.  T he  ori gi nal  of  t he 
writte n  i nf or me d  c o nse nt  f or m  s h o ul d  be  retai ne d  b y  t he  i n vesti gat or.  I n  ge neral,  t he 
i n vesti gat or m ust  o btai n  c o nse nt fr o m  a  patie nt pers o nall y. H o we ver,  if  t he  i n vesti gat or 
deter mi nes  t hat  a  patie nt’s  decisi o nal  ca pacit y  is  s o  li mite d  t hat  he  or  s he  ca n n ot 
reas o na bl y  be  c o ns ulte d  or  he  or  s he  is  a  mi n or,  c o nse nt  is  o btai ne d  fr o m  le gall y 
acce pta ble re prese ntati ve or pare nt(s). I n t his case, e ver y eff ort s h o ul d be ma de t o o btai n 
t he  patie nt’s  asse nt  as  far  as  p ossi ble  after  o btai ni n g  c o nse nt  fr o m  le gall y  acce pta ble 
re prese ntati ve or pare nt(s) if a mi n or. If t he st u d y patie nt d oes n ot pr o vi de his or her o w n 
c o nse nt,  t he  s o urce  d oc u me nts  m ust  rec or d  t he  relati o ns hi p  of  t he  pers o n  si g ni n g  t he 
c o nse nt a n d t he patie nt (e. g., pare nt(s), s p o use). If a mi n or r e gistere d i n t he st u d y reac hes 
a d ult h o o d  d uri n g  t he  st u d y,  t he  c o nse nt  will  be  ac q uire d  as  far   as  p ossi ble  fr o m  t he 
patie nt at t he ti me of a d ult h o o d acc or di n g t o Ja pa nese la w. 
At  t he  ti me  of  o btai ni n g  i nf or me d  c o nse nt,  t he  i n vesti gat or  m us t  use  i nf or me d  c o nse nt 
f or m  a n d  ot her  materials  a n d  e ns ure  t hat  eac h  st u d y  patie nt  or his  or  her  le gall y 
acce pta ble re prese ntati ve, or pare nt(s) if a mi n or,  is f ull y i nf or me d a b o ut t he i nf or mati o n 
pr o vi de d t o Pfizer a n d t he o bjecti v es of use a n d p ossi ble ris ks  ass ociate d wit h c o nse nt. 
9. 3.  I nstit uti o n al Re vie w B o ar d (IR B)/ Et hics C o m mittee ( E C) 
I n t his st u d y, re vie w b y t he I nstit uti o nal Re vie w B oar d (I R B)/ Et hics C o m mittee ( E C) is 
n ot re q uire d. 
9. 4.  Et hic al C o n d uct of t he St u d y 
T his  st u d y  will  be  c o n d ucte d  i n  c o m plia nce  wit h  t he  M H L W  Or di na nce  i n “ 6. 
R A TI O N A L E A N D B A C K G R O U N D.”  Als o, t he st u d y will be c o n d ucte d i n acc or da nce 
wit h le gal a n d re g ulat or y re q uire me nts, as well as wit h scie nti fic p ur p ose, val ue a n d ri g or. 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 7 of 3 7  
1 0.  M A N A G E M E N T A N D R E P O R TI N G  O F A D V E R S E E V E N T S A N D 
A D V E R S E D R U G R E A C TI O N S 
1 0. 1.  Re q uire me nts f or rec or di n g a n d re p orti n g 
T he ta ble bel o w s u m marizes t he r e q uire me nts f or rec or di n g safet y e ve nts o n t he C R F a n d 
f or re p orti n g safet y e ve nts o n t he N o n-I nter ve nti o nal St u d y A d verse E ve nt Re p ort F or m 
( NI S A E Re p ort F or m) t o Pfizer Safet y. T hese re q uire me nts are d eli neate d f or t hree t y pes 
of e ve nts: ( 1) seri o us a d verse e ve nts ( S A Es); ( 2) n o n-seri o us A Es (as a p plica ble); a n d ( 3) 
sce nari os i n v ol vi n g dr u g e x p os ure, i ncl u di n g e x p os ure d uri n g pr e g na nc y, e x p os ure 
d uri n g breast fee di n g, me dicati o n e rr or, o ver d ose, mis use, e xtra vasati o n, lac k of efficac y, 
a n d occ u pati o nal e x p os ure. T hese e ve nts are defi ne d i n t he sect i o n “ Defi niti o ns of safet y 
e ve nts.”   
S afet y e ve nt 
Rec or de d o n t he C R F 
Re p orte d o n t he NI S A E 
Re p ort F or m t o Pfizer S afet y 
wit hi n 2 4 h o urs of a w are ness 
S A E
All
All 
N o n-seri o us A E 
All 
N o ne   
Sce nari os i n v ol vi n g e x p os ure t o a 
dr u g u n der st u d y, i ncl u di n g 
e x p os ure d uri n g pre g na nc y, 
e x p os ure d uri n g breast fee di n g, 
me dicati o n err or, o ver d ose, mis use, 
e xtra vasati o n, lac k of efficac y, a n d 
occ u pati o nal e x p os ure 
All (re gar dless of w het her 
ass ociate d wit h a n A E), e xce pt 
occ u p ati o n al e x p os ure   
All (re gar dless of w het her 
ass ociate d wit h a n A E) 
N ote: A n y ass ociate d A E is 
re p orte d t o get her wit h t he 
e x p os ure sce nari o. 
 
F or eac h A E, t he i n vesti gat or m ust p urs ue a n d o btai n i nf or mati o n a de q uate b ot h t o 
deter mi ne t he o utc o me of t he A E  a n d t o assess w het her it meets t he criteria f or 
classificati o n as a S A E (refer t o secti o n " Seri o us a d verse e ve nts” bel o w).  
Safet y e ve nts liste d i n t he ta bl e a b o ve m ust be re p orte d t o Pfizer wit hi n 2 4 h o urs of 
a ware ness of t he e ve nt b y t he i n vesti gat or  re g ar dless of w het her t he e ve nt is 
deter mi ne d b y t he i n vesti g at or t o be rel ate d t o t his dr u g . I n partic ular, if t he S A E is 
fatal or life-t hreate ni n g, n otificati o n t o Pfizer m ust be ma de i m me diatel y, irres pecti ve of 
t he e xte nt of a vaila ble e ve nt inf or mati o n. T his ti mefra me als o a p plies t o a d diti o nal ne w 
(f oll o w- u p) i nf or mati o n o n pre vi o usl y f or war de d safet y e ve nt rep orts. I n t he rare sit uati o n 
t hat t he i n vesti gat or d oes n ot bec ome i m me diatel y a ware of t he occ urre nce of a safet y 
e ve nt, t he i n vesti gat or m ust re p ort t he e ve nt wit hi n 2 4 h o urs after lear ni n g of it a n d 
d oc u me nt t he ti me of his/ her fir st a ware ness of t he e ve nts. 
F or safet y e ve nts t hat are c o nsi d ere d seri o us or t hat are i de nt ifie d i n t he far ri g ht c ol u m n 
of t he ta ble a b o ve t hat are re p orta ble t o Pfizer wit hi n 2 4 h o ur s of a ware ness, t he 
i n vesti gat or is o bli gate d to p urs ue a n d t o pr o vi de a n y a d diti o n al i nf or mati o n t o Pfizer i n 
acc or da nce wit h t his 2 4- h o ur ti m efra me. I n a d diti o n, a n i n vesti gat or ma y be re q ueste d b y 
Pfizer t o o btai n s pecific f oll o w- u p i nf or mati o n i n a n e x pe dite d fas hi o n. T his i nf or mati o n 
is m ore detaile d t ha n that rec or de d o n t he C R F . I n ge neral, t his will i ncl u de a descri pti o n 
of t he A E i n s ufficie nt detail t o all o w f or a c o m plete me dical assess me nt of t he case a n d 
i n de pe n de nt deter mi nati o n of p ossi ble ca usalit y. A n y i nf or mati on rele va nt t o t he e ve nt, 
s uc h as c o nc o mita nt me dicati o ns a n d ill nesses, m ust be pr o vi de d . I n t he case of a patie nt 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 8 of 3 7  
deat h, a s u m mar y of a vaila ble a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o 
Pfizer or its desi g na te d re prese ntati ve. 
1 0. 2.  Re p orti n g peri o d 
F or eac h patie nt, t he safet y e ve nt re p orti n g peri o d be gi ns at t he ti me of  t he  patie nt’s first 
d ose of t his dr u g  a n d lasts t hr o u g h t he e n d of t he o bser vati o n peri o d of t he st u d y, w hic h 
m ust i ncl u de at least 2 8 cale n da r da ys f oll o wi n g t he last a d mi nistrati o n of a dr u g u n der 
st u d y; a re p ort m ust be s u b mitted t o Pfizer Safet y ( or its desi g nate d re prese ntati ve) f or 
a n y of t he t y pes of safet y e ve nts liste d i n t he ta ble a b o ve occ urri n g d uri n g t his peri o d. If a 
patie nt was a d mi nistere d a dr u g u n der st u d y o n t he last da y of t he o bser vati o n peri o d, 
t he n t he re p orti n g peri o d s h o ul d be e xte n de d f or 2 8 cale n dar days f oll o wi n g t he e n d of 
o bser vati o n. 
If t he i n vesti gat or bec o mes a ware of a S A E occ urri n g at a n y ti m e after c o m pleti o n of t he 
st u d y a n d s/ he c o nsi ders t he S A E t o be relate d t o t his dr u g, t he S A E als o m ust be re p orte d 
t o Pfizer Safet y. 
1 0. 3.  C a us alit y assess me nt 
T he i n vesti gat or is re q uire d t o assess a n d rec or d t he ca usal re lati o ns hi p. F or all A Es, 
s ufficie nt i nf or mati o n s h o ul d be o btai ne d b y the i n vesti gat or t o deter mi ne t he ca usalit y of 
eac h A E. F or A Es wit h a ca usal relati o ns hi p t o t his dr u g, f oll o w- u p b y t he i n vesti gat or is 
re q uire d u ntil t he e ve nt a n d/ or its se q uelae res ol ve or sta bili ze at a le vel acce pta ble t o t he 
i n vesti gat or, a n d Pfizer c o ncurs wit h t hat assess me nt.  
A n i n vesti gat or’s ca usalit y asse ss me nt is t he deter mi nati o n of w het her t here e xists a 
reas o na ble p ossi bilit y t hat t his dr u g ca use d or c o ntri b ute d t o a n A E. If t he i n vesti gat or’s 
fi nal deter mi nati o n of ca usalit y is “ u n k n o w n” a n d s/ he ca n n ot deter mi ne w het her t his 
dr u g ca use d t he e ve nt, t he safet y e ve nt m ust be re p orte d wit hi n  2 4 h o urs.  
If t he i n vesti gat or ca n n ot deter mi ne t he eti ol o g y of t he e ve nt b ut s/ he deter mi nes t hat t his 
dr u g di d n ot ca use t he e ve nt, t his s h o ul d be clearl y d oc u me nte d  o n t he C R F a n d t he NI S 
A E Re p ort F or m. 
1 0. 4.  Defi niti o ns of  s afet y e ve nts 
1 0. 4. 1.  A d verse e ve nts 
A n A E is a n y u nt o war d me dical occ u rre nce i n a patie nt a d mi nistere d a me dici nal pr o d uct. 
T he e ve nt nee d n ot necessaril y ha ve a ca usal relati o ns hi p wit h t he pr o d uct treat me nt or 
usa ge. E xa m ples of A Es i ncl u de b ut are n ot l i mite d t o:   
•  A b n or mal test fi n di n gs (see bel o w f or circ u msta nces i n w hic h a n  a b n or mal test 
fi n di n g c o nstit utes a n A E); 
•  Cli nicall y si g nifica nt si g ns a n d s y m pt o ms; 
•  C ha n ges i n p h ysical e xa mi nati o n fi n di n gs; 
•  H y perse nsiti vit y; 
•  Pr o gressi o n/ w orse ni n g o f u n derl yi n g disease;  
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 2 9 of 3 7  
•  Lac k of efficac y;  
•  Dr u g a b use;  
•  Dr u g de pe n de nc y. 
A d diti o nall y, f or me dic i nal pr o d ucts, t he y ma y i ncl u de t he si g ns or s y m pt o ms res ulti n g 
fr o m: 
•  Dr u g o ver d ose; 
•  Dr u g wit h dra wal; 
•  Dr u g mis use;  
•  Off-la bel use;  
•  Dr u g i nteracti o ns; 
•  E xtra vasati o n; 
•  E x p os ure d uri n g pre g na nc y; 
•  E x p os ure d uri n g breast fee di n g; 
•  Me dicati o n err or; 
•  Occ u pati o nal e x p os ure. 
A b n or mal test fi n di n gs 
T he criteria f or deter mi ni n g w het her a n a b n or mal o bjecti ve test  fi n di n g s h o ul d be 
re p orte d as a n A E are as f oll o ws:  
•  Test res ult is ass ociate d wit h acc o m pa n yi n g s y m pt o ms, a n d/ or 
•  Test res ult re q uires a d diti o nal dia g n ostic  testi n g or me dical/sur gical i nter ve nti o n, 
a n d/ or 
•  Test res ult lea ds t o a c ha n ge i n st u d y d osi n g or disc o nti n uati o n fr o m t he st u d y, 
si g nifica nt a d diti o nal c o nc o mita nt dr u g treat me nt, or ot her t hera p y, a n d/ or 
•  Test res ult is c o nsi dere d t o be  a n A E b y t he i n vesti gat or or s po ns or. 
Merel y re peati n g a n a b n or mal t est, i n t he a bse nce of a n y of t he  a b o ve c o n diti o ns, d oes 
n ot c o nstit ute a n A E. A n y a b n or mal test res ult t hat is deter mi n e d t o be a n err or d oes n ot 
re q uire re p orti n g as a n A E. 
1 0. 4. 2.  Seri o us a d verse e ve nts 
A S A E is a n y u nt o war d me dical occ u rre nce i n a patie nt a d mi nistere d a me dici nal or 
n utriti o nal pr o d uct (i ncl u di n g pe diatric f or m ulas) at a n y d ose t hat: 
•  Res ults i n deat h; 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 3 0 of 3 7  
•  Is life-t hreate ni n g; 
•  Re q uires i n patie nt h os pitaliza ti o n or pr ol o n gati o n of h os pitalizati o n (see bel o w f or 
circ u msta nces t hat d o n ot c o nstit ute A Es); 
•  Res ults i n persiste nt or si g nifica nt disa bilit y/i nca pacit y (s u b sta ntial disr u pti o n of t he 
a bilit y t o c o n d uct n or mal life f u ncti o ns); 
•  Res ults i n c o n ge nital a n o mal y/ birt h defect. 
Me dical a n d scie ntific j u d g me nt is e xercise d i n deter mi ni n g w he t her a n e ve nt is a n 
i m p orta nt me dical e ve nt. A n i m p orta nt me dical e ve nt ma y n ot be i m me diatel y life-
t hreate ni n g a n d/ or res ult i n deat h or h os pitaliz ati o n. H o we ver,  if it is determi ne d t hat t he 
e ve nt ma y je o par dize t he patie nt  or ma y re q uire i nter ve nti o n t o pre ve nt o ne of t he ot her 
o utc o mes liste d i n t he defi niti o n a b o ve, t he i m p orta nt me dical e ve nt s h o ul d be re p orte d as 
seri o us. 
E xa m ples of s uc h e ve nts are i nte nsi ve treat me nt i n a n e mer ge nc y  r o o m or at h o me f or 
aller gic br o nc h os pas m; bl o o d d yscr asias or c o n v ulsi o ns t hat d o n ot res ult i n 
h os pitalizati o n; or de vel o p me n t of dr u g de pe n de nc y or dr u g a b use. 
A d diti o nall y, a n y s us pecte d tra ns missi o n via a Pfizer pr o d uct o f a n i nfecti o us a ge nt, 
pat h o ge nic or n o n- pat h o ge nic, is c o nsi dere d seri o us. T he e ve nt ma y be s us pecte d fr o m 
cli nical s y m pt o ms or la b orat or y fi n di n gs i n dicati n g a n i nfecti o n i n a patie nt e x p ose d t o a 
Pfizer pr o d uct. T he ter ms “s us pec te d tra ns missi o n” a n d “tra ns missi o n” are c o nsi dere d 
s y n o n y m o us. T hese cases are c o nsi dere d u ne x pecte d a n d ha n dle d as seri o us e x pe dite d 
cases b y p har mac o vi gila nce ( P V) pe rs o n nel. S uc h cases are als o c o nsi dere d f or re p orti n g 
as pr o d uct defects, if a p pr o priate.  
H os pitalizati o n 
H os pitalizati o n is defi ne d as a n y i nitial a d missi o n (e ve n if le ss t ha n 2 4 h o urs) t o a 
h os pital or e q ui vale nt healt hcare facilit y or a n y pr ol o n gati o n t o a n e xisti n g a d missi o n. 
A d missi o n als o i ncl u des tra nsfer  wit hi n t he h os pital t o a n ac ute/i nte nsi ve care u nit (e. g., 
fr o m t he ps yc hiatric wi n g t o a me dical fl o or, me dical fl o or t o a c or o nar y care u nit, 
ne ur ol o gical fl o or t o a t u berc u l osis u nit). A n e mer ge nc y r o o m visit d oes n ot necessaril y 
c o nstit ute a h os pitalizati o n;  h o we ver, a n e ve nt lea di n g t o a n emer ge nc y r o o m visit s h o ul d 
be assesse d f or me d ical i m p orta nce.  
H os pitalizati o n i n t he a bse nce of a  me dical A E is n ot i n itself a n A E a n d is n ot re p orta ble. 
F or e xa m ple, t he f oll o wi n g re p orts of h os pitalizati o n wit h o ut a  me dical A E are n ot t o be 
re p orte d.  
•  S ocial a d missi o n (e. g., patie nt has n o place t o slee p) 
•  A d mi nistrati ve a d missi o n (e. g., f or yearl y e xa m) 
•  O pti o nal a d missi o n n ot ass ociate d w it h a preci pitati n g me dical A E (e. g., f or electi ve 
c os metic s ur ger y) 
•  H os pitalizati o n f or o bser vati o n wit h o ut a me dical A E 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 3 1 of 3 7  
•  A d missi o n f or treat me nt of a pre-e xisti n g c o n diti o n n ot ass ocia te d wit h t he 
de vel o p me nt of a ne w A E or wit h a  w orse ni n g of t he pre-e xisti n g c o n diti o n (e. g., f or 
w or k- u p of persiste nt pre- treat me nt la b a b n or malit y) 
1 0. 4. 3.  Sce n ari os necessit ati n g re p orti n g t o Pfizer S afet y wit hi n 2 4 h o urs 
Sce nari os i n v ol vi n g e x p os ure d uri n g pre g na nc y, e x p os ure d uri n g breastfee di n g, 
me dicati o n err or, o ver d ose, mis us e, e xtra vasati o n, lac k of effi cac y, a n d occ u pati o nal 
e x p os ure are descri be d bel o w.  
E x p os ure d uri n g pre g na nc y 
A n e x p os ure d uri n g pre g na nc y ( E D P) occ urs if: 
1.  A fe male bec o mes, or is f o u n d t o be , pre g na nt eit her w hile recei vi n g or ha vi n g bee n 
e x p ose d t o (e. g., e n vir o n me ntal) t his dr u g, or t he fe male bec o mes, or is f o u n d t o be, 
pre g na nt after disc o nti n ui n g a n d/ or bei n g e x p ose d t o  t his dr u g ( mater nal e x p os ure). 
A n e xa m ple of e n vir o n me ntal e x p os ure w o ul d be a case i n v ol vi n g direct c o ntact wit h 
a Pfizer pr o d uct i n a pre g na nt  w o ma n (e. g., a n urse re p orts t hat s he is pre g na nt a n d 
has bee n e x p ose d t o c he m ot hera pe utic pr o d ucts). 
2.  A male has bee n e x p ose d, eit her d ue  t o treat me nt or e n vir o n me ntal e x p os ure t o t his 
dr u g pri or t o or ar o u n d t he ti me of  c o nce pti o n a n d/ or is e x p osed d uri n g t he part ner 
pre g na nc y ( pater nal e x p os ure). 
 F or e x p os ure d uri n g pre g na nc y in st u dies of pre g na nt w o me n, da ta o n t he e x p os ure t o t he 
dr u g d uri n g pre g na nc y, are n ot re p or ta ble u nless ass ociate d with seri o us or n o n-seri o us 
a d verse e ve nts. 
As a ge neral r ule, pr os pecti ve a n d retr os pecti ve e x p os ure d uri n g pre g na nc y re p orts fr o m 
a n y s o urce are re p orta b le irres pecti ve of the prese nce of a n as s ociate d A E a n d t he 
pr oce d ures f or S A E re p orti n g s h o u l d be f oll o we d, wit h t he e xce pti o n of t h ose st u dies 
c o n d ucte d i n pre g na nt w o me n (as d escri be d i n a b o ve), f or w hic h data o n t he e x p os ure are 
n ot re p orta ble u nless ass ociate d wit h seri o us or n o n-seri o us a d verse e ve nts.  
 
If a st u d y partici pa nt or st u d y partici pa nt’s part ner bec o mes, or is f o u n d t o be, pre g na nt 
d uri n g t he st u d y partici pa nt’s treat me nt wit h t his dr u g,  t his i nf or mati o n m ust be 
s u b mitte d t o Pfizer, irres pecti ve of w het her a n A E has occ urre d  usi n g t he NI S A E Re p ort 
F or m a n d t he E D P S u p ple me ntal F or m.  
I n a d diti o n, t he i nf or mati o n re gar di n g e n vir o n me ntal e x p os ure to t his dr u g i n a pre g na nt 
w o ma n (e. g., a patie nt re p orts t hat s he is pre g na nt a n d has bee n e x p ose d t o a c yt ot o xic 
pr o d uct b y i n halati o n or s pilla ge)  m ust be s u b mitte d usi n g t he NI S A E Re p ort F or m a n d 
t he E D P S u p ple me ntal F or m. T his m ust be d o ne irres pecti ve of w h et her a n A E has 
occ urre d.  
I nf or mati o n s u b mitte d s h o ul d i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or 
i nf or mati o n relate d t o ter mi nati o n of pre g na nc y). 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 3 2 of 3 7  
F oll o w- u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y; i n a d diti o n, 
f oll o w- u p is c o n d ucte d t o o btai n i nf or mati o n o n E D P o utc o me f or all E D P re p orts wit h 
pre g na nc y o utc o me u n k n o w n. A pre g na nc y is f oll o we d u ntil c o m ple ti o n or u ntil 
pre g na nc y ter mi nati o n (e. g., i n d u ce d a b orti o n) a n d Pfizer is n o tifie d of t he o utc o me. T his 
i nf or mati o n is pr o vi de d as a f oll o w u p t o t he i nitial E D P re p ort. I n t he case of a li ve birt h, 
t he str uct ural i nte grit y of t he ne o nate ca n be assesse d at t he ti me of birt h. I n t he e ve nt of a 
ter mi nati o n, t he reas o n(s) f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, 
t he str uct ural i nte grit y of t he ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual 
i ns pecti o n ( u nless pre- pr oce d ure test fi n di n gs are c o ncl usi ve for a c o n ge nital a n o mal y 
a n d t he fi n di n gs are re p orte d). 
If t he o utc o me of t he pre g na nc y meets t he criteria f or a n S A E ( e. g., ect o pic pre g na nc y, 
s p o nta ne o us a b orti o n, i ntra uteri ne fetal de mise, ne o natal deat h , or c o n ge nital a n o mal y [i n 
a li ve b or n, a ter mi nate d fet us , a n i ntra uteri ne fetal de mise, or a ne o natal deat h]), t he 
pr oce d ures f or re p orti n g S A Es s h o ul d be f oll o we d. 
A d diti o nal i nf or mati o n a b o ut pre g na nc y o utc o mes t hat are re p ort e d as S A Es f oll o ws:  
•  S p o nta ne o us a b orti o n i ncl u des miscarria ge a n d misse d a b orti o n; 
•  Ne o natal deat hs t hat occ ur w it hi n 1 m o nt h of birt h s h o ul d be rep orte d, wit h o ut re gar d 
t o ca usalit y, as S A Es. I n a d ditio n, i nfa nt deat hs after 1 m o nt h s h o ul d be re p orte d as 
S A Es w he n t he i n vesti gat or asse sses t he i nfa nt deat h as relate d  or p ossi bl y relate d t o 
e x p os ure t o i n vesti gati o nal pr o d uct. 
A d diti o nal i nf or mati o n re gar di n g t he e x p os ure d uri n g pre g na nc y ma y be re q ueste d. 
F urt her f oll o w- u p of birt h o utc o mes will be ha n dle d o n a case- b y-case basis (e. g., f oll o w-
u p o n preter m i nfa nts t o i de ntif y de vel o p me ntal dela ys).  
I n t he case of pater nal e x p os ure, t he st u d y partici pa nt will be pr o vi de d wit h t he Pre g na nt 
Part ner Release of I nf or mati o n F or m t o deli ver t o his part ner. It m ust be d oc u me nte d t hat 
t he st u d y partici pa nt was gi ve n this letter t o pr o vi de t o his p art ner. 
E x p os ure d uri n g breastfee di n g 
Sce nari os of e x p os ure d uri n g brea stfee di n g m ust be re p orte d, ir res pecti ve of t he prese nce 
of a n ass ociate d A E. A n e x p os ure  d uri n g breastfee di n g re p ort is n ot create d w he n a Pfizer 
dr u g s pecificall y a p pr o ve d f or us e i n breastfee di n g w o me n (e. g. , vita mi ns) is 
a d mi nistere d i n acc or d wit h a ut h orize d use. H o we ver, if t he i nfa nt e x perie nces a n A E 
ass ociate d wit h s uc h a dr u g’s a d mi nistrati o n, t he A E is re p orte d t o get her wit h t he 
e x p os ure d uri n g breastfee di n g. 
Me dicati o n err or 
A me dicati o n err or is a n y u ni nte nti o nal err o r i n t he prescri bi ng, dis pe nsi n g, or 
a d mi nistrati o n of a me dici nal pr o d uct t hat ma y ca use or lea d t o  i na p pr o priate me dicati o n 
use or patie nt har m w hile i n t he  c o ntr ol of t he healt h care pr ofessi o nal, patie nt, or 
c o ns u mer. S uc h e ve nts ma y be rel ate d t o pr ofessi o nal practice, healt h care pr o d ucts, 
pr oce d ures, a n d s yste ms i ncl u di n g: prescri bi n g; or der c o m m u nica ti o n; pr o d uct la beli n g, 
pac ka gi n g, a n d n o me nclat ure; c o m p o u n di n g; dis pe nsi n g; distri b ut i o n; a d mi nistrati o n; 
e d ucati o n; m o nit ori n g; a n d use.  
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 3 3 of 3 7  
Me dicati o n err ors i ncl u de: 
•  Near misses, i n v ol vi n g or n ot i n v o l vi n g a patie nt directl y (e. g., 
i na d verte nt/err o ne o us a d mi nistrati o n, w hic h is t he acci de ntal use of a pr o d uct 
o utsi de of la beli n g or prescri p ti o n o n t he part of t he healt hcare pr o vi der or t he 
patie nt/c o ns u mer); 
•  C o nf usi o n wit h re gar d t o i n ve nte d na me (e. g., tra de na me, bra n d  na me). 
T he i n vesti gat or m ust s u b mit t he f oll o wi n g me dicati o n err ors t o Pfizer, irres pecti ve of t he 
prese nce of a n ass ociate d A E/ S A E: 
•  Me dicati o n err ors i n v ol vi n g patie n t e x p os ure t o t he pr o d uct, w het her or n ot t he 
me dicati o n err or is a cc o m pa nie d b y a n A E. 
•  Me dicati o n err ors t hat d o n ot i n v ol ve a patie nt directl y (e. g.,  p ote ntial me dicati o n 
err ors or near misses). W he n a  me dicati o n err or d oes n ot i n v ol ve patie nt e x p os ure 
t o t he pr o d uct t he f oll o wi n g mi ni m u m criteria c o nstit ute a me dicati o n err or re p ort: 
•  A n i de ntifia ble re p orter; 
•  A s us pect pr o d uct; 
•  T he e ve nt me dicati o n err or. 
O ver d ose, Mis use, E xtra vasati o n 
Re p orts of o ver d ose, mis use, a n d e xtra vasati o n ass ociate d wit h t he use of a Pfizer pr o d uct 
are re p orte d t o Pfizer b y t he i n vesti gat or, irres pecti ve of t he  prese nce of a n ass ociate d 
A E/ S A E. 
Lac k of Efficac y 
Re p orts of lac k of efficac y t o a P fizer pr o d uct are re p orte d t o Pfizer b y t he i n vesti gat or, 
irres pecti ve of t he prese nce of an ass ociate d A E/ S A E or t he i n d icati o n f or use of t he 
Pfizer pr o d uct. 
Occ u pati o nal E x p os ure 
Re p orts of occ u pati o nal e x p os ure t o  a Pfizer pr o d uct are re p orte d t o Pfizer b y t he 
i n vesti gat or, irres pecti ve of the prese nce of a n ass ociate d A E/ S A E. 
1 1.  P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S 
I nf or mati o n  c ollecte d  i n  t his  st u d y  will  be  use d  f or  re p orti n g p ur p oses  t o  re p ort  t he 
Mi nistr y of Healt h, La b o ur a n d Welfare ( M H L W), P har mace uticals a n d Me dical De vices 
A ge nc y ( P M D A), Pfizer I nc. w hic h is t he c or p orate pare nt of s p ons or of t his st u d y, a n d 
t he  gr o u p  c o m pa nies,  or  re g ulat or y  a ge nc y  i n  ot her  c o u ntries.  Als o,  it  will  be  use d  f or 
s u b mitti n g  a p plicati o n  of  re-e xa mi nati o n  (i ncl u di n g  Peri o dic  Safet y  U p date  Re p ort),  re-
e val uati o n,  pre parati o n  of  mater ial  f or  pr o per  use  i nf or mati o n of  L O R A- PI T A, 
p u blicati o ns a n d acti vi ties f or i nf or mati o n pr o visi o n. I n a d dit i o n, Pfizer ma y discl ose t he 
st u d y res ults t o pr o vi de i nf or mati o n f or pr o per use, as nee de d, o n w w w.cli nicaltrials. g o v 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 3 4 of 3 7  
( Cli nical Trials. g o v),  as  prese ntati o ns  at  aca de mic  c o nfere nces,  or as pa pers, etc. 
 
Data  o btai ne d  fr o m  t he  patie nts re gistere d  i n  t his  St u d y  will  be  re p orte d  t o  t he  M H L W 
p urs ua nt  t o  t he  P har mace utical  a n d  Me dical  De vice  Act.  I n  t his case,  t he  data  ma y  be 
p u blicl y  p oste d  i n  t he  M H L W’s  “ P har mace utical  a n d  Me dical  De vic e  Safet y 
I nf or mati o n”  a n d  “ P har mace uticals  a n d  Me dical  De vices  I nf or matio n  We bsite 
( htt p:// w w w.i nf o. p m da. g o.j p)”  as  a  listi n g  of  patie nts,  w hic h  will  i ncl u de  t he  na mes  of 
dr u gs,  a d verse  reacti o ns,  ge n der,  a ge  (i ncre me nts  of  1 0  years),   a n d  ot her  rele va nt 
i nf or mati o n. F urt her m ore, data collecte d ma y als o be discl ose d if t he M H L W is re q uire d 
t o discl ose s uc h i nf or mati o n i n acc or da nce wit h t he “ Act o n Access t o I nf or mati o n Hel d 
b y A d mi nistrati ve Or ga ns” ( La w N o. 4 2 date d Ma y 1 4, 1 9 9 9); pr o v i de d t hat i n n o e ve nt 
will  t he  na mes  of  p h ysicia ns,  st u d y  sites,  a n d  ot her  pers o nal  i nf or mati o n  be  s u bject  t o 
s uc h discl os ure, n or will it be p oste d or discl ose d. 
I n t he e ve nt of a n y pr o hi biti o n or restricti o n i m p ose d (e. g., cli nical h ol d) b y a n a p plica ble 
C o m pete nt A ut h orit y i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n  w hic h  mi g ht  i nfl ue nce  t he  e val uati o n  of  t he  be nefits  a n d  ris ks  of  a  Pfizer 
pr o d uct, Pfizer s h o ul d be i n f or me d i m me diatel y. 
1 2.  N A M E, A N D A D D R E S S O F C O N T R A C T O R A S W E L L A S S C O P E O F 
W O R K C O N T R A C T E D 
C o m pa n y na me: Pfizer R & D Ja pa n 
A d dress: 3- 2 2- 7, Y o y o gi, S hi b u ya- k u, T o k y o 
Sc o pe of w or k c o ntracte d: Pla n ni n g of st u d y, drafti n g of pla n, i m ple me ntati o n of st u d y 
a n d m o nit ori n g, etc. 
C o m pa n y na me: Me di data S ol uti o ns 
A d dress: 2- 7- 2, Mar u n o uc hi, C hi y o da- k u, T o k y o 
Sc o pe of w or k c o ntracte d: Esta b lis h me nt, o perati o n a n d mai nte nance of t he E D C 
s yste m, etc. 
C o m pa n y na me: A 2 Healt hcare C or p orati o n 
A d dress: 1- 4- 1, K ois hi ka wa, B u n k y o- k u, T o k y o 
Sc o pe of w or k c o ntracte d: E D C acc o u nt ma na ge me nt w or ks  
 
C o m pa n y Na me: E P S C or p orati o n  
A d dress: 2- 2 3 S hi m o mi ya bic h o, S hi nj u k u- k u, T o k y o 
Sc o pe of w or k c o ntracte d: Re gistrati o n, data ma na ge me nt, statis tical a nal ysis etc. 
( w or ks e xcl u di n g t he ma na ge me nt of t he p ost- mar keti n g st u d y) 
1 3.  A D DI TI O N A L M E A S U R E S T H A T M A Y B E I M P L E M E N T E D B A S E D O N 
T H E S T U D Y R E S U L T S A N D C RI T E RI A  F O R D E T E R MI N A TI O N O F T H E 
I NI TI A TI O N 
Re vie w  t he  ris k  ma na ge me nt  pla n i ncl u di n g  t he  f oll o wi n g  c o nte nts  at  t he  sc he d ule d 
ti mi n g of milest o nes: 
•  Re vie w t he necessit y f or c ha n gi n g t he c o nte nts of ris k mi ni miza ti o n acti vities f or t he 
c urre nt safet y s pecificati o ns. 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 3 5 of 3 7  
•  Re vie w t he necessit y f or c ha n gi n g t he c o nte nts of t his st u d y pl a n i ncl u di n g t he 
prese nce or a bse nce of ne w safet y s pecificati o ns (c o nti n uati o n of t he st u d y, 
i m ple me ntati o n of a d diti o nal st u d y, etc.). 
•  Re vie w t he necessit y f or f or m ula ti n g ris k mi ni mizati o n meas ures  f or ne w safet y 
s pecificati o ns. 
1 4.  S C H E D U L E D TI MI N G O F MI L E S T O N E S A N D T H EI R R A TI O N A L E S F O R 
E V A L U A TI O N O F S T U D Y I M P L E M E N T A TI O N S T A T U S A N D R E S U L T S A N D 
R E P O R TI N G T O T H E P M D A 
Safet y re vie w a n d re p orti n g at t he ti me of pre pari n g t he Peri o d ic Safet y U p date Re p orts 
a n d c o m pleti o n of t he st u d y. 
1 5.  O T H E R N E C E S S A R Y M A T T E R S 
1 5. 1.  A me n d me nt of t he St u d y Pr ot oc ol 
Base d o n t he ne w k n o wle d ge t o be o btai ne d acc or di n g t o t he pr o g ress of t his st u d y, t he 
nee d  f or  a me n d me nt  of  t he  pr ot oc ol  will  be  e xa mi ne d  a n d  t he  St u d y  Pr ot oc ol  will  be 
a me n de d  if  necessar y.  Als o,  t he  nee d  f or  a me n d me nt  of  t he  St u d y   Pr ot oc ol  will  be 
e xa mi ne d  a n d  t he  pr ot oc ol  will  be  a me n de d  w he n  t he  partial  c ha n ge  i n  t he  d osa ge  a n d 
a d mi nistrati o n  or  i n dicati o n  is  a p pr o ve d  d uri n g  t he  ree xa mi nati o n  peri o d  (e xce pt  w he n 
t he ree xa mi nati o n peri o d is ne wl y desi g nate d), etc. 
1 5. 2.  Acti o ns t o be t a ke n f or a n y pr o ble m or iss ue 
Re visi o n of t he pac ka ge i nsert a n d c o n d uct of a ne w p ost- mar ket i n g s ur veilla nce or ne w 
p ost- mar keti n g  cli nical  trial  s h o ul d  be  c o nsi dere d  f or  t he  f oll o wi n g  cases:  A n y  seri o us 
a n d  u n k n o w n  a d verse  reacti o n  is  s u g geste d;  a  si g nifica nt  i ncrea se  i n  t he  fre q ue nc y  of 
a d verse reacti o ns;  a n y  efficac y  o r safet y c o ncer n  c o m pare d  t o  pre-a p pr o val;  a n d/ or  rare 
a d verse reacti o n is s u g geste d. 
1 6.  C O N T A C T I N F O R M A TI O N 
1 6. 1.  C o nt act i nf or m ati o n f or i n q uiries a b o ut t he st u d y 
Na me 
P M S Affairs, Pfizer R & D Ja pa n  
A d dress 
3- 2 2- 7, Y o y o gi, S hi b u ya- k u, T o k y o 1 5 1- 8 5 8 9 
Fa x 
0 3- 5 3 0 9- 9 1 8 6 
E- mail a d dress  L O R A PI T A _ P M S @ pfizer.c o m 
1 6. 2.  C o nt act i nf or m ati o n f or i n q ui ries a b o ut t he E D C s yste m 
Na me 
Me di data Hel p des k 
B usi ness h o urs 
Wee k da ys: 9: 0 0- 2 0: 0 0 ( e xcl u di n g Sat ur da ys, S u n da ys, a n d h oli da ys a n d 
year-e n d a n d Ne w Year h oli da ys)  
Tel 
 ( Pfizer de dicate d li ne) 
E- mail a d dress  ja pa n hel p des k @ m ds ol.c o m 
 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)
P P D

L ora pita 
B 3 5 4 1 0 0 3 N O N-I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
A me n de d 4, 0 4 Se pte m ber 2 0 2 3  
 
 
P FI Z E R C O N FI D E N TI A L 
C T 2 4- WI-J P N- G P S P 0 1- R F 0 9 7. 0 N o n-I nter ve nti o nal St u d y Pr ot oc ol T e m plate f or Sec o n dar y Data 
C ollecti o n St u d y 1 5- Se p- 2 0 2 2 
Pa ge 3 6 of 3 7  
1 7.  R E F E R E N C E S 
1.  Ge neral I n vesti gati o n: Re gistrati o n F or m 
2.  Ge neral I n vesti gati o n: Case Re p ort F or m 
3.  Trei ma n D M, et al. N E n gl J Me d 1 9 9 8; 3 3 9: 7 9 2 – 7 9 8. 
4.   All dre d ge B K, et al. N E n gl J Me d 2 0 0 1; 3 4 5: 6 3 1 – 6 3 7. 
5.   Sil ber gleit R, et al. N E n gl J Me d 2 0 1 2; 3 6 6: 5 9 1 – 6 0 0. 
6.   C ha m berlai n J M, et al. J A M A 2 0 1 4; 3 1 1: 1 6 5 2- 1 6 6 0. 
1 8.  LI S T O F T A B L E S 
Pa ge 1 4 Ta ble 1. Varia bles a n d sc he d ule of o bser vati o n 
Pa ge 1 6  Ta ble 2. E pile ptic Sei z ure T y pe Classificati o n (I L A E, 1 9 8 1 versi o n) 
Pa ge 2 1 Ta ble 3. Cl o p per- Pears o n t w o-si de d 9 5 % c o nfi de nce i nter val ( N = 1 2 0 or 6 0) 
Pa ge 2 4 Ta ble 4. Cli nical st u dies  t o be use d as refere nces w he n e xa mi ni n g t he res ults of 
t he dr u g use i n vesti gati o n 
1 9.  LI S T O F FI G U R E S 
N ot a p plica ble  
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S 
N ot a p plica ble 
A N N E X 2. A D DI TI O N A L I N F O R M A TI O N 
1.  Ge neral I n vesti gati o n: Re gistrati o n F or m 
2.  Ge neral I n vesti gati o n: Case Re p ort F or m 
 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)

 
T R A N S L A TI O N R E C O R D 
( F O R P O S T- M A R K E TI N G S U R V EI L L A N C E S T U D Y I N J A P A N) 
1 0- J a n- 2 0 1 9 
 
P FI Z E R C O N FI D E N TI A L 
Pa ge 1 of 1 
 
D oc u me nt T y pe
実施要綱 v 5. 0  
D oc u me nt D ate 
( Ori gi n al)
0 4 Se pte m ber 2 0 2 3  
Pr o gr a m
B 3 5 4  
St u d y
B 3 5 4 1 0 0 3 
Ori gi n al L a n g u a ge
日本語 
Site
N A 
Tr a nsl ati o n L a n g u a ge
英語 
Is a b ac k 
tr a nsl ati o n 
re q uire d ?
N O 
 
 
F U L L T R A N S L A TI O N A N D R E VI E W I N F O R M A TI O N 
 
Tr a nsl at or Q u alific ati o n 
T y pe 
Tra nslati o n ve n d or 
Tr a nsl ati o n Ve n d or  
H o n ya k u Ce nter I nc. 
Tr a nsl at or N a me 
H o n ya k u Ce nter I nc. 
D ate of Tr a nsl ati o n 
1 7 O C T 2 0 2 3 
Re vie wer N a me 
D ate of Re vie w 
0 9 N O V 2 0 2 3 
 
 
0 9 0 1 7 7 e 1 9f 5 c 2 0 1 6\ A p pr o v e d\ A p pr o v e d O n: 0 4- D e c- 2 0 2 3 0 8: 0 8 ( G M T)
P P D