Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis)
Conditions: Rheumatoid Arthritis
Sponsor: Pfizer

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 of 3 4
( A p pe n di x)
I nfli xi m a b B S f or I ntr a ve n o us Dri p I nf usi o n 1 0 0 m g " Pfizer "
Ge ner al i n vesti g ati o n
( R he u m at oi d Art hritis)
N O N -I N T E R V E N TI O N A L( NI) S T U D Y F U L L 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 Pfizer.  E xce pt as ot her w ise 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 ve nt 
of a n y act ual or s us pecte d breac 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 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 of 3 4
S T U D Y I N F O R M A TI O N
Title
I nfli xi ma b B S f or Intra ve n o us Dri p I nf usi o n 1 0 0 m g 
"Pfizer "
Ge neral I n vesti gati o n ( R he u mat oi d Art hritis)
Pr ot oc ol n u m ber
B 5 3 7 1 0 0 6
Pr ot oc ol versi o n i de ntifier
Versi o n 6
D ate
1 8 Oct o ber 2 0 2 2
Acti ve s u bst a nce
I nfli xi ma b ( ge netical rec o m bi nati o n) [i nfli xi ma b 
bi osi milar 3]
Me dici n al pr o d uct
I nfli xi ma b B S f or Intra ve n o us Dri p I nf usi o n 1 0 0 m g 
"Pfizer "
Rese arc h q uesti o n a n d 
o bjecti ves
T o c ollect i nf or mati o n o n t he safet y a n d effecti ve ness of 
I nfli xi ma b B S f or Intra ve n o us Dri p I nf usi o n 1 0 0 m g 
"Pfizer " a gai nst r he u mat oi d art hritis u n der act ual st at us 
of use.
A ut h or
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)
P P D
P P D

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 3 of 3 4
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 T I 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 .......................................................................................8
5. MI L E S T O N E S .......................................................................................................................9
6. R A TI O N A L E A N D B A C K G R O U N D ..................................................................................9
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 0
7. 1. Safet y s pecificati o ns ................................................................................................1 0
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. St u d y  sites...................................................................................................1 1
8. 2. 3. Pla n ne d st u d y  peri o d...................................................................................1 1
8. 2. 4. St u d y  pr oce d ures ........................................................................................1 1
8. 2. 4. 1. St u d y  met h o d.............................................................................1 1
8. 2. 5. O bser vati o n peri o d ......................................................................................1 1
8. 3. Varia bles ..................................................................................................................1 2
8. 3. 1. Patie nt c haracteristics .................................................................................1 4
8. 3. 2. Pri or a n d c o nc o mita nt me dicati o ns ............................................................1 5
8. 3. 2. 1. Dr u gs use d t o treat r he u mat oi d art hritis ....................................1 5
8. 3. 2. 2. Dr u gs use d t o pre ve nt i nfecti o n (i ncl u di n g vacci nes) ...............1 5
8. 3. 2. 3. D r u gs use d t o pre ve nt i nf usi o n reacti o n....................................1 5
8. 3. 2. 4. Dr u gs use d t o treat a d verse e ve nts............................................ 1 5
8. 3. 3. N o n- dr u g t hera pies .....................................................................................1 6
8. 3. 3. 1. N o n- dr u g t hera pies t o treat r he u mat oi d art hritis .......................1 6
8. 3. 3. 2. N o n- dr u g t hera pies t o treat a d verse e ve nts ...............................1 6
8. 3. 4. Tar gete d dr u g use ....................................................................................... 1 6
8. 3. 5. Tests ............................................................................................................1 6
8. 3. 6. Cli nical e val uati o n of effecti ve ness ............................................................1 7
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 4 of 3 4
8. 3. 6. 1. O bser vati o n ite ms ......................................................................1 7
8. 3. 6. 2. Effecti ve ness e val uati o n scale ...................................................1 7
8. 3. 7. Prese nce or a bse nce of pre g na nc y  ( w o me n o nl y).......................................1 7
8. 3. 8. C o nfir mati o n of t he da y  of st u dy c o m pleti o n a n d a d mi nistrati o n stat us ....1 7
8. 3. 9. A d verse e ve nts ............................................................................................1 8
8. 4. A d verse e ve nts of n ote ............................................................................................1 9
8. 5. Data s o urces ............................................................................................................1 9
8. 6. St u d y  size ................................................................................................................1 9
8. 6. 1. Pla n ne d sa m ple size ....................................................................................1 9
8. 6. 2. Rati o nale f or sa m ple size ............................................................................1 9
8. 7. Data ma na ge me nt ....................................................................................................1 9
8. 7. 1. Case re p ort f or ms ( C R Fs)/ Electr o nic data rec or d .....................................1 9
8. 7. 2. Rec or d rete nti o n ..........................................................................................2 0
8. 7. 3. Data c ollecti o n met h o d ( E D C) ...................................................................2 0
8. 7. 4. Patie nt re gistrati o n ( E D C) ..........................................................................2 0
8. 7. 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 case 
re p ort f or m ( E D C)............................................................................................2 0
8. 7. 5. 1. Data e ntr y ..................................................................................2 0
8. 7. 5. 2. Data re visi o n .............................................................................2 1
8. 7. 5. 3. S u b missi o n ................................................................................2 1
8. 8. Data a nal y sis ...........................................................................................................2 1
8. 8. 1. Defi niti o n of a nal ysis set ............................................................................2 1
8. 8. 2. Met h o d of a nal ys is......................................................................................2 1
8. 8. 2. 1. A nal y sis f or safet y e val uati o n...................................................2 1
8. 8. 2. 2. A nal y sis f or effecti ve ness e val uati o n ........................................2 1
8. 9. Q ualit y  c o ntr ol.........................................................................................................2 1
8. 1 0. L i mitati o ns of t he researc h met h o ds .....................................................................2 1
8. 1 1. Ot her as pects......................................................................................................... 2 2
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 2
9. 1. Patie nt i nf or mati o n ..................................................................................................2 2
9. 2. Patie nt c o nse nt .........................................................................................................2 2
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 5 of 3 4
9. 3. I ns tit uti o nal re vie w b oar d (I R B)/I n de pe n de nt et hics c o m mittee (I E C) ..................2 3
9. 4. Et hical c o n d uct of t he st u d y ....................................................................................2 3
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 D V E R S E 
R E A C TI O N S ......................................................................................................................2 4
1 0. 1. Re q uire me nts .........................................................................................................2 4
1 0. 2. Re p o rti n g peri o d....................................................................................................2 5
1 0. 3. Ca usalit y  assess me nt.............................................................................................2 5
1 0. 4. D efi niti o ns of safet y e ve nts ...................................................................................2 6
1 0. 4. 1. A d verse e ve nts.......................................................................................... 2 6
1 0. 4. 2. Seri o us a d verse e ve nts ..............................................................................2 7
1 0. 4. 3. Sce nari os necessitati n g re p orti n g t o Pfizer Safet y  wit hi n 2 4 h o urs .........2 8
1 1. P L A N S F O R DI S S E M I NA 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 1
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 2
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 R I TE 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 2
1 4. S C H E D U L E D TI MI N G O F M I L E S T O N E S A N D TH 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 LE 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 3
1 5. O T H E R N E C E S S A R Y M A T T E R S ..................................................................................3 3
1 5. 1. A me n d me nt of t he F ull Pr ot oc ol ...........................................................................3 3
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 3
1 6. C O N T A C T I N F O R M A T I O N............................................................................................3 3
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 3
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 4
1 7. R E F E R E N C E S ..................................................................................................................3 4
1 8. LI S T O F T A B L E S .............................................................................................................3 4
1 9. LI S T O F FI G U R E S ...........................................................................................................3 4
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 4
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 4
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 6 of 3 4
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
C R P
C -reacti ve pr otei n 
C T
C o m p ute d T o m o gra p h y
D A S
Disease Acti vit y  Sc ore
E D C
Electr o nic data ca pt ure 
N/ A
N ot a p plica ble
S A P
Statistical a nal y sis pla n
V A S
Vis ual A nal o g ue Scale 
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 7 of 3 4
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
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 8 of 3 4
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
Date
Pr ot oc ol secti o n(s) 
c ha n ge d
S u m mar y of a me n d me nt(s)
Reas o n
A me n de d 5
Oct o ber 1 8, 
2 0 2 2
St u d y I nf or mati o n 
a n d secti o n 1 6. 1
Secti o n n u m bers
Secti o n 5
Secti o n 6
Secti o n 1 0
Pre vi o us secti o n 1 2
Secti o n 1 2
Secti o n 1 6. 2
Ge neral
C ha n ge of a ut h or na me a n d 
de part me nt na me
T he ta ble of c o nte nts has 
bee n re n u m bere d t o 1, a n d 
all secti o n n u m bers ha ve 
bee n re vise d
A d diti o n of ite ms
C ha n ge of mi nisterial 
or di na nces
C ha n ge of ter ms
Deleti o n
A d diti o n of o uts o urce d 
ser vices, etc.
C ha n ge of c o ntact 
i nf or mati o n
E diti n g of descri pti o ns 
ass ociate d wit h re visi o n of 
t he sta n dar d te m plate
D ue t o c ha n ge of a ut h or a n d 
de part me nt na me
Beca use t he sta n dar d 
te mplate was re vise d
Beca use t he sta n dar d 
te mplate was re vise d
D ue t o partial re visi o n of 
mi nisterial or di na nces
D ue t o c ha n ge of i nter nal 
f or m
Beca use t he sta n dar d 
te mplate was re vise d
D ue t o c ha n ge i n sc o pe of 
o uts o urce d ser vices a n d t he 
sta n dar d te m plate was 
re vise d
D ue t o c ha n ge of c o ntact 
i nf or mati o n
Beca use t he sta n dar d 
te mplate was re vise d
A me n de d 4 . 1
J u ne 1 3, 2 0 2 2
Fr o nt c o ver
C ha n ge of C o m pa n y L o g o
D ue t o c ha n ge of t he 
c o m pa n y l o g o
A me n de d 4
M a y  3 0, 2 0 1 9
Secti o n 9
Secti o n 1 6. 2
Ge neral
C ha n ge of ter ms
C ha n ge of e -mail a d dress 
f or i n q uiries
Sta n dar dizati o n of 
e x pressi o ns
D ue t o c ha n ge of i nter nal 
f or m
D ue t o c ha n ge of e -mail 
a d dress
A dj ust me nt of descri pti o n
A me n de d 3
Fe br uar y 1 5, 
2 0 1 9
Secti o ns 4
C ha n ge i n i n vesti gati o n 
sc he d ule
T he date of pre parati o n of 
t he fi nal re p ort was 
c ha n ge d.
A me n de d 2
Ja n uar y 1 0, 
2 0 1 9
Secti o ns 4 a n d 
7. 2. 3
Secti o ns 8. 1 a n d 
8. 2
Ge neral
C ha n ge i n i n vesti gati o n 
sc he d ule
Descri pti o n of o btai ni n g 
i nf or me d c o nse nt fr o m 
patie nts t o be s ur ve ye d 
re gar di n g discl os ure, 
D ue t o re visi o n of t he 
pr ot oc ol
Beca use it was deci de d t o 
o btai n c o nse nt fr o m t he 
patie nts t o be s ur ve ye d 
re gar di n g t he use of 
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 9 of 3 4
p u blicati o n, etc. of s ur ve y 
res ults
E diti n g of descri pti o ns 
ass ociate d wit h re visi o n of 
t he stan dar d te m plate
i n vesti gati o n res ults f or 
ot her p ur p oses.
Beca use t he sta n dar d 
te mplate was re vise d.
A me n de d 1
Dece m ber 1, 
2 0 1 8
Secti o n 1 3
Secti o n 1 7. 1
C o ntract or w as a d de d
C ha n ge i n t he na me of t he 
c o ntact

Esta blis h me nt of Pfizer
R & D Ja pa n
Fi nal
J ul y 3 1, 2 0 1 8
N A
N A
N A
5. MI L E S T O N E S
Milest o ne
Pl a n ne d d ate
Start of i n vesti gati o n peri o d
Fe br uar y 2 0 1 9
Start of data c ollecti o n
2 0 Marc h 2 0 1 9
E n d of i n vesti gati o n peri o d
A u g ust 2 0 2 4
E n d of data c ollecti o n
1 2 Marc h 2 0 2 5
Fi nal st u d y re p ort
Se pte m ber 2 0 2 5
6. R A TI O N A L E A N D B A C K G R O U N D
I nfli xi ma b B S f or Intra ve n o us Dri p I nf usi o n 1 0 0 m g "Pfizer " ( ge neric na me, i nfli xi ma b 
[ ge netical rec o m bi nati o n] [i nfli xi ma b bi osi milar 3]) ( herei nafter, t his dr u g) is a dr u g de vel o pe d 
b y  Pfizer as a bi osi milar of t he ori gi nal bi o p har mace utical Re mica de (t he ge neric na me a n d 
bra n d na me of t he pr o d uct a p pr o ve d i n Ja pa n are i nfli xi ma b [ ge netical rec o m bi nati o n] a n d 
Re mica de f or I ntra ve n o us Dri p I nf usi o n 1 0 0, res pecti vely).
I n I nfli xi ma b B S f or I ntra ve n o us Dri p I nf usi o n 1 0 0 m g "Pfizer " Dr u g Use I n vesti gati o n 
( R he u mat oi d Art hritis) ( herei nafter, t his st u d y), i nf or mati o n of t he safet y a n d effecti ve ness of 
t his dr u g a gai nst r he u mat oi d art hritis u n der act ual stat us of use will be c ollecte d.
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 f oll o wi n g mi nisterial or di na nces a n d 
n otificati o ns:

" M H LW
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 nce N o. 1 7 1, date d Dece m ber 2 0, 2 0 0 4)

" E nf orce me nt of t he M H LW 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" ( 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 dical 
Pr o d ucts " (M H L W Or di na nc e N o. 1 3 5 , date d Se pte m ber 2 2, 2 0 0 4)
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 0 of 3 4

" E nf orce me nt of t he M H LW 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, a n d Me dical De vices, 
Re ge nerati ve Me dical Pr o d ucts " ( P F S B N otificati o n N o. 0 8 12- 4, date d A u g ust 1 2, 2 0 1 4)

" M H LW 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 nce N o. 1 1 6, 
date d Oct o ber 2 6, 2 0 1 7) 

"A n n o u nce me nt of t he M H L W Or di na nce t o P artiall y A me n d t he M H LW 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 
( 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 Me dical Pr o d ucts) " ( P S E H B N otificati 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 o c ollect i nf or mati o n o n t he safet y a n d effecti ve ness of t his dr u g a gai nst r he u mat oi d art hritis 
u n der act ual stat us of use.
7. 1. S afet y s pecific ati o ns
[I m p ort a nt I de ntifie d Ris ks]

Dela y e d-t ype h y perse nsiti vit y

L u p us -li ke sy n dr o me ass ociate d wit h ser oc o n versi o n of a nti -ds D N A a nti b o d y

De m y eli nati n g disease

He patic i m pair me nt

Seri o us i nf usi o n reacti o n

R ha b d o m y ol ys is

Reacti vati o n of he patitis B

A nti b o d y  pr o d ucti o n
[I m p ort a nt P ote nti al Ris ks]

I nfectio n d ue t o i n oc ulati o n of li ve vacci nes i n c hil dre n
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 1 of 3 4
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 ulti-ce nter c o h ort st u d y of patie nts wit h r he u mat oi d art hritis recei vi n g t his dr u g. 
T he i n vesti gat ors c o m plete t he case re p ort f or m ( C R F) base d o n t he me dica l rec or d c o ntai ni n g 
data o btai ne d i n dail y me dical practice.
8. 2. Setti n g
Patie nts meeti n g t he re gistrati o n c o n diti o ns will be i ncl u de d i n t his st u d y.
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 be eli gi ble f or i ncl usi o n i n t he st u d y:
1.
Patie nts wit h r he u mat oi d art hritis w h o starte d treat me nt wit h t his dr u g
2.
Patie nts w h o recei ve d t his dr u g f or t he first ti me after t he da y of la u nc h of t his dr u g.
See t he latest pac ka ge i nsert i n a d mi nisteri n g t his dr u g.
8. 2. 2. St u d y sites
C o n d uct t he st u d y at 1 5 0 t o 2 0 0 sites i ncl u di n g t he De part me nt of R he u mat ol o g y, De part me nt of 
Ort h o pe dics, De part me nt of C olla ge n Disease, etc.
8. 2. 3. Pl a n ne d st u d y peri o d
T he pla n ne d peri o d c o vere d b y t his st u d y is as f oll o ws.
I n vesti gati o n peri o d : Fe br uar y 2 0 1 9 t o A u g ust 2 0 2 4
Re gistrati o n peri o d: Fe br uar y  2 0 1 9 t o Ja n uar y 2 0 2 4
8. 2. 4. St u d y pr oce d ures 
8. 2. 4. 1. St u d y met h o d
Ce ntral re gistrati o n s ys te m: Patie nts meeti n g t he re gistrati o n c o n diti o ns will be re gistere d u ntil 
t he tar get sa m ple size is reac he d.
8. 2. 5. O bser v ati o n peri o d
T he o bser vati o n peri o d is 3 0 wee ks * fr o m t he da y of i nitial d ose of t his dr u g ( Da y 1). 
I nf or mati o n u p t o t he da y of visit i m me diatel y after 8 wee ks ha ve ela pse d si nce t he last d ose 
d uri n g t he o bser vati o n peri o d ( da y  of st u dy c o m pleti o n) will be c ollecte d i n t his st u d y .
* : T he peri o d of 3 0 wee ks is defi ne d as u p t o Da y 2 1 7 i n c o nsi derati o n f or all o wa nce i n visit 
da y s t hat occ ur i n dail y me dical practice.
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 2 of 3 4
8. 3. V ari a bles
T his st u d y  will be c o n d ucte d i n acc or da nce wit h t he o bser vati o n sc he d ule i n T a ble 1 .
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 3 of 3 4
T a ble 1.
V ari a bles a n d Sc he d ule of o bser v ati o n
Ti m i n g
Varia bles
Re gistrati o n 
f or m
C R F
At re gistrati o n
At 
c o m me nce me nt 
of treat me nt
Fr o m  
c o m me nce me nt 
of treat me n t t o 
da y of st u d y 
c o m pleti o n
Patie nt 
de m o gra p hics
I de ntificati o n n u m ber
●
Ge n der
●
●
A ge at c o m me nce me nt of treat me nt wit h 
t his dr u g
●
●
Date of c o m me nce me nt of treat me nt wit h 
t his dr u g
●
C hec k of re gistrati o n c o n diti o ns
●
Hei g ht
●
Wei g ht
●
Tar get disease, disease sta ge/ pr o gressi o n, 
le vel of d ysf u ncti o n, a n d d urati o n of 
ill ness
●
Prese nce or a bse nce a n d res ults of 
t u berc ul osis scree ni n g test, a n d rec or d of 
a d mi nistrati o n of a ntit u berc ul osis dr u gs
●
Prese nce or a bse nce a n d res ults of he patitis 
B vir us test a n d he patitis C vir us test
●
S m o k i n g hist or y
●
Fa m il y hist or y of mali g na nt t u m ors 
(i ncl u di n g l y m p h o ma)
●
Me dical hist or y ( past hist or y a n d 
c o m plicati o ns) (i ncl u di n g t he prese nce or 
a bse nce of aller gic hist or y a n d he patic 
i mpair me nt)
●
Prese nce or a bse nce a n d d urati o n of past 
use of i nfli xi ma b pre parati o ns
●
Pri or a n d c o nc o mita nt me dicati o ns
●
●
N o n -dr u g t hera pies
●
●
Rec or d of a d mi nistrati o n of t his dr u g
●
●
*
Tests
●
●
Effecti ve ness e val uati o n
O bser vati o n ite ms: N u m ber of te n der j oi nts, n u m ber of 
s wolle n j oi nts, patie nt’s assess me nt of o verall acti vit y 
( patie nt V A S), a n d C-reacti ve pr otei n ( C R P)
●
●
Prese nce or a bse nce of pre g na nc y ( w o me n o nl y)
●
●
C o nfir mati o n of t he da y of st u d y c o m pleti o n a n d 
a d mi nistrati o n stat us
●
A d verse e ve nts
●
●
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 4 of 3 4
*: I nf or mati o n o n t he use of t his dr u g fr o m t he da y of i nitial d ose t o t he last d ose d uri n g t he o bser vati o n peri o d ( 3 0 wee ks)
will be c ollecte d.
8. 3. 1. P atie nt c h ar acteristics 
I nf or m ati o n at c o m me nce me nt of tre at me nt wit h t his dr u g will be e ntere d i n t he 
re gistr ati o n f or m.
1.
I de ntificati o n n u m ber
2.
Ge n der
3.
A ge at c o m me nce me nt of treat me nt wit h t his dr u g
4.
Date of c o m me nce me nt of treat me nt wit h t his dr u g
5.
C hec k of re gistrati o n c o n diti o ns
T he f oll o wi n g i nf or m ati o n at c o m me nce me nt of tre at me nt wit h t his dr u g will be e ntere d i n 
t he C R F.
1.
Hei g ht (c m)
2.
Wei g ht ( k g)
3.
Ge n der
4.
A ge at c o m me nce me nt of treat me nt wit h t his dr u g
5.
Tar get disease, disease sta ge/ pr o gressi o n ( Stei n br oc ker’s classificati o n of disease sta ge), 
le vel of dys f u ncti o n ( Stei n br oc ker’s classificati o n of f u ncti o n), a n d d urati o n of ill ness 
( date of dia g n osis)
6.
Prese nce or a bse nce a n d res ults of t u berc ul osis scree ni n g test ( dia g n ostic 
i ma gi n g/t u berc uli n reacti o n test/i nterfer o n γ release test [ Q ua nti Fer o n Test, T s p ot test, 
etc.]) a n d rec or d of a d mi nistrati o n of a ntit u berc ul osis dr u gs
7.
Prese nce or a bse nce a n d res ults of he patitis B vir us test a n d he patitis C vir us test ( H Bs 
a nti ge n, H Bs a nti b o d y, H Bc a nti b o dy, a n d H C V a nti b o d y )
8.
S m o ki n g hist or y
9.
Fa mil y  hist or y of mali g na nt t u m ors (i ncl u di n g ly m p h o ma)
1 0. Me dical hist or y  ( past hist or y a n d c o m plicati o ns) (i ncl u di n g t he prese nce or a bse nce of 
aller gic hist or y a n d he patic i m pair me nt)
1 1. Prese nce or a bse nce a n d d urati o n of past use of i n fli xi ma b pre parati o ns
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 5 of 3 4
8. 3. 2. Pri or a n d c o nc o mit a nt me dic ati o ns
8. 3. 2. 1. Dr u gs use d t o tre at r he u m at oi d art hritis
T he f oll o wi n g i nf or mati o n will be e ntere d f or dr u gs use d t o treat r he u mat oi d art hritis 
i m me diatel y bef ore t he i nitial d ose of t his dr u g a n d c o nc o mita nt me dicati o ns use d t o treat 
r he u mat oi d art hritis bet wee n t he da y of i nitial d ose of t his dr u g a n d t he da y of st u d y c o m pleti o n.
1.
Na me of dr u g ( pr o d uct na me)
2.
R o ute of a d mi nistrati o n
3.
Peri o d of a d mi nistrati o n
4.
Reas o n f or disc o nti n uati o n (i na de q uate effecti ve ness/a d verse e ve nt/ ot hers)
8. 3. 2. 2. Dr u gs use d t o pre ve nt i nfecti o n (i ncl u di n g v acci nes)
T he f oll o wi n g i nf or mati o n will be e ntere d f or dr u gs use d t o pre ve nt i nfecti o n (i ncl u di n g 
vacci nes) bet wee n 6 m o nt hs bef ore t he da y  of i nitial d ose of t his dr u g a n d t he da y of st u dy 
c o m pleti o n.
1.
Na me of dr u g ( pr o d uct na me)
2.
R o ute of a d mi nistrati o n
3.
Peri o d of a d mi nistrati o n
4.
T otal dail y  d ose a n d fre q ue nc y of a d mi nistrati o n
5.
Tar get of pr o p h yl actic a d mi nistrati o n
8. 3. 2. 3. Dr u gs use d t o pre ve nt i nf usi o n re acti o n
T he f oll o wi n g i nf or mati o n will be e ntere d f or dr u gs use d t o pre ve nt i nf usi o n reacti o n fr o m 
bef ore t he i nitial d ose of t his dr u g t o t he da y  of st u d y c o m pleti o n.
1.
Na me of dr u g ( pr o d uct na me)
2.
R o ute of a d mi nistrati o n
3.
Peri o d of a d mi nistrati o n
4.
T otal dail y  d ose a n d fre q ue nc y of a d mi nistrati o n
8. 3. 2. 4. Dr u g s use d t o tre at a d verse e ve nts
T he f oll o wi n g i nf or mati o n will be e ntere d f or dr u gs use d t o treat a d verse e ve nts bet wee n t he da y 
of i nitial d ose of t his dr u g a n d t he da y  of st u dy c o m pleti o n.
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 6 of 3 4
1.
Na me of dr u g ( pr o d uct na me)
2.
R o ute of a d mi nistrati o n
3.
Peri o d of a d mi nistrati o n
8. 3. 3. N o n- dr u g t her a pies
8. 3. 3. 1. N o n- dr u g t her a pies t o tre at r he u m at oi d art hritis
T he f oll o wi n g i nf or mati o n will be e ntere d f or n o n -dr u g t hera pies perf or me d t o treat r he u mat oi d 
art hritis bet wee n 6 m o nt hs bef ore t he da y  of i nitial d ose of t his dr u g a n d t he da y of st u d y 
c o m pleti o n.
1.
Na me of t hera p y ( na me of pr oce d ure f or s ur ger y , etc.)
2.
Peri o d of i m ple me ntati o n
8. 3. 3. 2. N o n- dr u g t her a pies t o tre at a d verse e ve nts
T he f oll o wi n g i nf or mati o n will be e ntere d f or n o n -dr u g t hera pies perf or me d t o treat a d verse 
e ve nts bet wee n t he d a y of i nitial d ose of t his dr u g a n d t he da y of st u dy c o m pleti o n.
1.
Na me of t hera p y ( na me of pr oce d ure f or s ur ger y , etc.)
2.
Peri o d of i m ple me ntati o n
8. 3. 4. T ar gete d dr u g use
T he f oll o wi n g i nf or mati o n will be e ntere d f or t he stat us of use of t his dr u g bet wee n t he da y  of 
i nitial d ose of t his dr u g a n d t he last d ose d uri n g t he o bser vati o n peri o d ( 3 0 wee ks ).
1.
D ose
2.
Wei g ht
3.
Date of a d mi nistrati o n
4.
Reas o n f or c ha n ge
8. 3. 5. Tests
T he res ults of tests perf or me d bet wee n 3 m o nt hs bef ore t he da y of i nitial d ose of t his dr u g a n d 
t he da y of st u dy c o m pleti o n will be e ntere d.
1.
Prese nce or a bse nce of c hest X -ra y or c hest C T, a n d prese nce or a bse nce of a b n or mal 
fi n di n gs
2.
La b orat or y  tests: K L-6 a n d - D-gl uca n ( meas ure d ra n ges a n d site refere nce ra n ges)
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 7 of 3 4
8. 3. 6. Cli nic al e v al u ati o n of effecti ve ness
Effecti ve ness will be e val uate d base d o n t he res ults of t he f oll o wi n g o bser vati o n ite ms.
8. 3. 6. 1. O bser v ati o n ite ms
T he res ults of t he f oll o wi n g ite ms fr o m bef ore t he i nitial d ose of t his dr u g (i ncl u di n g t he da y of 
i nitial d ose) t o t he da y of st u d y c o m pleti o n will be e ntere d.
1.
N u m ber of te n der j oi nts (assess me nt of 2 8 j oi nts)
2.
N u m ber of s w olle n j oi nts (assess me nt of 2 8 j oi nts)
3.
Patie nt’s assess me nt of o verall acti vit y ( patie nt V A S)
( T he le vel of o verall disease acti vit y of r he u mat oi d art hritis is assesse d.)
4.
C- reacti ve pr otei n ( C R P)
8. 3. 6. 2. Effecti ve ness e v al u ati o n sc ale
T he f oll o wi n g will be calc ulate d base d o n i nf or mati o n c ollecte d f or o bser vati o n ite ms t o e val uate 
disease acti vit y .

Disease Acti v it y Sc ore ( D A S) 2 8
8. 3. 7. Prese nce or a bse nce of pre g n a nc y ( w o me n o nl y)
T he prese nce or a bse nce of pre g na nc y  bet wee n t he da y of i nitial d ose of t his dr u g a n d t he da y of 
st u d y c o m pleti o n will be e ntere d.
8. 3. 8. C o nfir m ati o n of t he d a y of st u d y c o m pleti o n a n d a d mi nistr ati o n st at us
T he f oll o wi n g i nf or mati o n will be e ntere d as t o w het her treat me nt wit h t his dr u g is o n g oi n g o n 
t he da y of st u dy c o m pleti o n.
1.
Date of st u d y c o m pleti o n
2.
W het her treat me nt is o n g oi n g
3.
Reas o n f or disc o nti n uati o n (c o m pleti o n) (c h o ose fr o m t he f oll o wi n g)
a.
Re mitte d (s y m pt o m i m pr o ve d)
b.
I na de q uate cli nical effect
c.
A d verse e ve nt (e nter necessar y  i nf or mati o n i n t he a d verse e ve nt c ol u m n)
d.
N o re visit
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 8 of 3 4
e.
Ot hers (e nter reas o ns f or disc o nti n uati o n)
8. 3. 9. A d verse e ve nts
A n A d verse E ve nt( A E) is a n y  u nt o war d me dical occurre nce i n a patie nt a d mi nistere d a 
me dici nal pr o d uct.
Occ urre nce of a d verse e ve nts fr o m t he da y of i nitial d ose of t his dr u g a n d t he da y of st u dy 
c o m pleti o n 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 by 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 reacti o ns n ot liste d i n t he pac ka ge i nsert.
1.
Prese nce/a bse nce of a d verse e ve nts
2.
Na me of a d verse e ve nt
3.
Cate g or y  of a d verse e ve nt ( w het her it falls u n der i nf usi o n reacti o n a n d ti mi n g of o nset)
4.
Date of occ urre nce
5.
I nter ve nti o n
6.
Seri o us ness
7.
O utc o me
8.
Date of o utc o me
9.
Ca usal relati o ns hi p t o t his dr u g
If t he a d verse e ve nt is ass ociate d wit h a b n or mal la b orat or y val ues, i.e., cli nical la b orat or y tests, 
t he f oll o wi n g i nf or mati o n s h o ul d als o be rec or de d.
1 0. Prese nce /a bse nce of tests relate d t o a d verse e ve nts
1 1. Date of test
1 2. Na me of test
1 3. Site refere nce val ue
1 4. U nit
1 5. Res ults of test
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 1 9 of 3 4
8. 4. A d verse e ve nts of n ote
A d verse e v e nts of n ote i n t his st u d y are s h o w n bel o w.
Seri o us i nfecti o n ( p ne u m o nia, P ne u m oc y stis p ne u m o nia, se psis, o p p ort u nistic i nfecti o n, etc.), 
t u berc ul osis, dela ye d -t ype h y perse nsiti vit y , seri o us bl o o d dis or der, l u p us-li ke s yn dr o me 
ass ociate d wit h ser oc o n versi o n of a nti -ds D N A a nti b o d y , de myeli nati n g disease, he patic 
i m pair me nt, seri o us i nf usi o n reacti o n, i nterstitial p ne u m o nia, r ha b d o my o l ysis, reacti vati o n of 
he patitis B, a nti b o d y pr o d ucti o n, mali g na nt t u m or, a n d i nfecti o n d ue t o i n oc ulati o n of li ve 
vacci nes i n c hil dre n
8. 5. D at a s o urces
I n t his st u dy, t he i n vesti gat ors tra nscri be t he necessar y i nf or mati 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 ot oc ol.
8. 6. St u d y size
8. 6. 1. Pl a n ne d s a m ple size
Tar get sa m ple size is t o be 3 0 0 s u bjects f or sa fety a nal ys is.
8. 6. 2. R ati o n ale f or s a m ple size
T he data c ollecte d fr o m 3 0 0 s u bjects t o w h o m t his dr u g is a d mi nistere d s h o ul d e na ble t o detect 
a n d verif y, wit h a pr o ba bilit y of 9 5 %, at least 1 s u bject i n w h o m eac h a d verse e ve nt wit h a n 
i nci de nce of 1 % or m ore occ urs.
T he i nci de nces of i nf usi o n reacti o n, h y p erse nsiti vit y, a n d he patic i m pair me nt are e x pecte d t o be 
hi g her t ha n t h ose of ot her e ve nts base d o n t he res ults of cli nical st u dies. Ass u mi n g t hat t he 
i nci de nces of i nf usi o n reacti o n, h yperse nsiti vit y , a n d he patic i m pair me nt i n dr u g use 
i n vesti gati o ns are 5 %, 1 0 %, a n d 5 %, res pecti vel y, t he pr o ba bilit y t hat acc u m ulati o n of 
3 0 0 patie nts all o ws c ollecti o n of eac h e ve nt i n 1 0 or m ore patie nts is a p pr o xi matel y  9 4 % or m ore 
f or eac h e ve nt.
T he fre q ue ncies of seri o us i nf usi o n reacti o n a n d dela y e d-t ype h y p erse nsiti vit y are pres u me d t o 
be l o w beca use seri o us i nf usi o n reacti o n was o bser ve d i n 1 patie nt b ut dela ye d -t ype 
h y perse nsiti vit y  was n ot o bser ve d i n a gl o bal p hase 3 st u d y of t his dr u g. T heref ore, i n t his st u d y, 
i nf or mati o n o n t he occ urre nce of i nf usi o n reacti o n a n d h y perse nsiti vit y will be wi del y c ollecte d 
t o ta b ulate t heir i nci de nces a n d perf or m fact orial a nalys es, a n d t hese e ve nts will als o be 
e val uate d fr o m t he sta n d p oi nts of seri o us ness a n d w het her t he y were treate d.
8. 7. D at a m a n a ge me nt 
8. 7. 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 .
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 0 of 3 4
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 patie 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 ypte d electr o nic f or m a n d will be pass w or d pr otecte d 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 data 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 uri n 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 
the 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 ginal e ntr y .
T he s o urce d oc u me nts are t he h os pital or t he p h ys icia 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. 7. 2. Rec or d rete nti o n
T he rec or ds relate d t o t his st u d y  s h o ul d be retai ne 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 he st u dy site, w hic he ver is l o n ger.
8. 7. 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 c ollecte d 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 (Electr o nic Data Ca pt ure, E D C).
8. 7. 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 patie nt re gistrati o n scree n of E D C 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 a d mi nistrati o n wit h 
t his dr u g.
If t here is s o met hi n g t o be c o nfir me d f o u n d i n t he re gistrati o n f or m, c o nfir mati o n will be 
re q ueste d wit h t he i n vesti gat or. Re gistrati o n will be fi xe d after t he c o nfir mati o n.
8. 7. 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. 7. 5. 1. D at a e ntr y
T he i n vesti gat or s hall, u p o n c o nfir mi n g t he st u d y  ite ms, i n p ut t he data i n t his s yste m base d o n 
me dical c harts, a n d sa ve t he data.
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 1 of 3 4
8. 7. 5. 2. D at a re visi o n 
U p o n recei vi n g S p o ns or's i n q uir y  o n t he c o nte nts of t he C R F (q uer y  f or ms), 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. 7. 5. 3. S u b missi o n
C R Fs s h o ul d be si g ne d electricall y b y t he i n vesti gat or u p o n c o m pleti o n.
8. 8. D at a a n al ysis 
8. 8. 1. Defi niti o n of a n al ysis set
T he safet y a nal ys is set ( S A S) will be a f ull a nal ys is 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 t his dr u g. T he effecti ve ness a nal ys is set will be a set of patie nts f or w h o m 
t he effecti ve ness e val uati o n is c o nsi dere d p ossi ble a m o n g t he safety a nal ys is set acc or di n g t o t he 
se paratel y prescri be d Statistical A nal ysis Pla n ( S A P).
8. 8. 2. Met h o d of a n al ysis
8. 8. 2. 1. A n al ysis f or s afet y e v al u ati o n
T he o nset of maj or a d verse reacti o ns a n d i nci de nce of a d verse reacti o ns ( perce nta ge of patie nts 
wit h a d verse e ve nts f or w hic h t he ca usal relati o ns hi p wit h t his dr u g ca n n ot be r ule d o ut) i n t he 
S A S will be a nal y z ed. I n a d diti o n, patie nt de m o gra p hics a n d i nci de nce will be ta b ulate d f or 
i nf usi o n reacti o n, hy p erse nsiti vit y, a n d he patic i m pair me nt i n t he S A S, a n d t hese e ve nts will be 
e val uate d i n ter m s of seri o us ness a n d w het her treat me nt was re q uire d.
8. 8. 2. 2. A n al ysis f or effecti ve ness e v al u ati o n
D A S 2 8 will be set as a n effecti ve ness e n d p oi nt, a n d t he val ues bef ore a n d after treat me nt will be 
descri pti vel y s u m marize d.
Detaile d met h o d ol o g y  f or s u m mar y a n d statistical a nalys es of data 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 ys is Pla n ( S A P), w hic h will be date d, file d a n d mai ntai ne d by 
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 ny m aj or m o dificati o ns of 
pri mar y  e nd p oi nt defi niti o ns or t heir a nal ys es w o ul d be reflecte d i n a pr ot oc ol a me n d me nt.
8. 9. 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 staff 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 a case re p ort f or m base d o n me dical 
c harts.
8. 1 0. 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:
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 2 of 3 4

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 mitati 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 d verse e ve nts a n d a d verse reacti o ns i ncreases wit h 
a d mi nistrati o n of t his dr u g.

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 1. 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 ws 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 will i ncl u de o mitti n g patie nt na mes or ot her direct l y i de ntifia ble data i n a ny 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 will be st ore d at t he st u d y  site i n [e ncr ypte 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 access. T he st u d y site will i m ple me nt a p pr o priate tec h nical a n d 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 res p o nsi ble f or deter mi ni n g w het 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 ms 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 Pfizer 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 pecifi c, n u merical c o de, base d o n a 
n u m beri n g s ys te m defi ne d b y Pfizer. All ot her i de ntifia ble data tra nsferre d t o Pfizer or ot her 
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 i n vesti gat or site 
will mai ntai n a c o nfi de ntial lis t 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 de 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 
sta n dar ds of c o nfi de ntialit y a n d pr otecti o n of patie nts’ pers o nal 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.
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 la w (e ve n t h o u g h t hat 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), 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 wit h re gar d t o t he pers o nal i nf or mati o n pr o visi o n fr o m t he 
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 3 of 3 4
st u d y site t o Pfizer. Als o, beca use t he re p ort of i nf or matio 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 by Pfizer as nee de d is a n i nf or mati o n 
pr o visi 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 dy, Pfizer wil l 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 
i nstit uti o ns. T he res ults of t his st u d y, w hic h are pre pare d n ot t o i de ntif y s pecific patie nts, ma y be 
re p orte d t o Pfizer I nc., w hic h is t he c or p orate pare nt of t he s p o ns or of t his st u d y,  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 it as a 
prese ntati o n at aca de mic c o nfere nces or ma n uscri pt f or t he p ur p ose of pr o vi di n g pr o per use 
i nf or mati o n f or t his dr u g. If t hese i nf or mati o n falls u n der pers onal 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 n se nt fr o m t he patie nt. T heref ore, t he st u d y i nstit uti o ns will 
o btai n writte n or ver bal 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 Inc., 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, or t o prese nt it at aca de mic c o nfere nces or p u blis h ma n uscri pt, etc. W het her 
c o nse nt is o btai ne d fr o m patie nts or n ot is descri be d i n t he C R F. 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 by t he st u d y i n vesti g at 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 nally. 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 bly b e 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 re 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 
reac 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 ust 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 ves 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 (I R B)/I n de pe n de nt et hics c o m mittee (I E C)
I n t his st u dy, re vie w b y t he I nstit uti o nal Re vie w B oar d (I R B)/I n de pe n de nt Et hics C o m mittee 
(IE 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 LW Or di na nce i n t he secti o 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 ntific p ur p ose, val ue a n d ri g or.
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 4 of 3 4
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 D V E R S E 
R E A C TI O N S
1 0. 1. Re q uire me nts
T he ta ble bel o w s u m marizes t he re 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 ( NI S) a d verse e ve nt m o nit ori n g ( A E M) 
Re p ort F or m t o Pfizer Safet y. T hese re q uire me nts are deli 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 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 effi cac 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 secti 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 M 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 oci ate 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 ble 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 by 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 
i nf 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 warde d safet y  e ve nt re p orts. I n t he rare sit uati o n t hat t he i n vesti gat or d oes n ot 
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 5 of 3 4
bec o me 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 first a ware ness of t he 
e ve nts.
F or safet y e ve nts t hat are c o nsi dere d seri o us or t hat are i de ntifie 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 urs of a ware ness, t he i n vesti gat or is 
o bli gate d t o p urs ue a n d t o pr o vi de a n y a d diti o nal 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 mefra 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 t hat 
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 o n 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 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 nate 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 5 6 cale n dar 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 bmitte d t o Pfizer Safet y  ( or its desi g nate d re prese ntati ve) f or a ny 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 rep orti n g peri o d s h o ul d be e xte n de d f or 
5 6 cale n dar da ys 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 ny ti me 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 relati 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 t he 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 bilize at a le vel acce pta ble t o t he i n vesti gat or, a n d Pfizer 
c o nc urs wit h t hat assess me nt.  
A n i n vesti gat or’s ca usalit y assess 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 used t he e ve nt, t he 
safety e ve nt m ust be re p orte d wit hi n 2 4 h o urs.  
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 6 of 3 4
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 NIS A E M Re p ort
F or m . 
1 0. 4. De fi 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 urre 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 li 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 ym pt o ms;

C ha n ges i n p h ys ical 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 of u n derl yi n g  disease; 

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 dici nal pr o d ucts , t he y ma y i ncl u de t he si g ns or sy 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;
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 7 of 3 4

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 or te 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  sy 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/s ur 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 p o ns or.
Merel y re peati n g a n a b n or mal test, 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 ne 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 urre 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 ula s) at a ny d ose t hat:

Res ults i n deat h;

Is life-t hreate ni n g;

Re q uires i n patie nt h os pitalizati 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 bsta 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 het 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 im me diatel y  life-t hreate ni n g a n d/ or res ult 
i n deat h or h os pitalizati o n. H o we ver, if it is deter mi 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 y scrasias 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 nt of dr u g de pe n de nc y or dr u g a b use.
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 8 of 3 4
A d diti o nall y , a ny s us pecte d tra ns missi o n via a Pfizer pr o d uct of 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 ym 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 pecte 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) 
pers 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 less 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 missio 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 ul 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 e mer ge nc y  r o o m visit s h o ul d be assesse d f or me dical 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 ort s 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 ye arl y e xa m)

O pti o nal a d missi o n n ot ass ociate d wit 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

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 ociate 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 p re-
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 use, e xtra vasati o n, lac k of efficac 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).
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 2 9 of 3 4
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 ose d 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  i n st u dies of pre g na nt w o me n, data o n t he e x p os ure t o dr u g 
d uri n g pre g na nc y , 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. 
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 ble irres pecti ve of t he prese nce of a n ass 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 ul 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 descri 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 dy 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 NIS A E M 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 t o 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 M 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 het 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).
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 o r 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 pleti o n or u ntil pre g na nc y ter mi nati o n (e. g., 
i n d uce d a b orti o n) a n d Pfizer is n otifie 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 grity 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 f or 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 maly [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.
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 3 0 of 3 4
A d d iti 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 orte 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 wit hi n 1 m o nt h of birt h s h o ul d be re p orte d, wit h o ut re gar d t o 
ca usalit y, as S A Es. I n a d diti o 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 assesses 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 req 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 dy 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 t his letter t o pr o vi de t o his part 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 breastfee di n g m ust be re p orte d, irres 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 pecifically a p pr o ve d f or use 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 or i n t he prescri bi n g, 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 relate d t o 
pr ofessi o nal practice, healt h care pr o d ucts, pr oce d ures, a n d s ys te ms i ncl u di n g: prescri bi n g; or der 
c o m m u nicati 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 uti o n; a d mi nistrati o n; e d ucati o n; m o nit ori n g; a n d use.  
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 ol 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 pti 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:
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 3 1 of 3 4

Me dicati o n err ors i n v ol vi n g patie nt 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 acc 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 by 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 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 or t he i n dicati o n f or use of t he Pfiz er 
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 t he 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 T I N G A N D C O M M U NI C A TI NG 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 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 t he s p o ns or of t his st u d y , a n d t he gr o u p c o m panies, 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 material f or 
pr o per use i nf or mati o n of t his dr u g, p u blicati o ns a n d ac ti vities f or i nf or mati o n pr o visi o n. In 
a d diti 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 ( Cli nical Trials. g o v), as prese ntati o ns at aca de mic c o nfere nces, or as 
ma n uscri pts, etc.   
Da ta 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 LW 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 
M H L W' s " P har mace utical a n d Me dical De vice Safety I nf or mati o n" a n d " Phar mace uticals a n d 
Me dical De vices I nf or mati o 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 nt of 1 0 years), 
a n d ot her rele va nt i nf or mati o n. F urt her m ore, data c ollecte d ma y als o be discl ose d if t he M H LW 
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 3 2 of 3 4
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 vi de d t hat i n n o e ve nt 
will t he na mes of p h ys icia ns, me dical i nstit uti o ns, 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 ny 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 worl 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 nf 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 y a-k u, T o k y o
Sc o pe of w or k c o ntracte d: W or ks relate d t o 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 dy 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 u c hi, C hi yo da -k u, T o k y o
Sc o pe of w or k c o ntracte d: Esta blis h me nt, o perati o n a n d mai nte na nce of t he E D C s y ste 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: C o ntract d uties, rece pti o n of re gistrati o n f or m, etc.

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: E sta blis h me nt of t he E D C s yste m, data ma na ge me nt d uties , 
a nal ys is d uties, etc.
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 R I T E RI A F O R D E T E R MI N ATI 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 mizati o n acti vities f or t he 
c urre nt safet y s pecificati o ns. 

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 pla 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.).
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 3 3 of 3 4

Re vie w t he nec essit y f or f or m ulati n g ris k mi ni mizati o n meas ures f or ne w safety 
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
Re vie w a n d re p ort t he safet y  e ver y yea r fr o m a p pr o val t o s u b missi o n of t he fi nal re p ort.
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 m e n d me nt of t he F ull 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 gress 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 F ull 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 F ull Pr ot oc ol 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 keti 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 n t i ncrease i n t he fre q ue nc y of a d verse reacti o ns; a ny 
effecti ve ness or safet y c o ncer n c o m pare d t o pre- a p pr o val; 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 y a-k u, T o k y o 1 5 1 -8 5 8 9
E- mail a d dress
I F X _ P M S @ pfizer.c o m 
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)

I nfli xi ma b Pfizer
B 5 3 7 1 0 0 6 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 5, 1 8 Oct o ber 2 0 2 2
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 Te 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
P a ge 3 4 of 3 4
1 6. 2. C o nt act i nf or m ati o n f or i n q uiries 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
M o n da y s t hr o u g h Fri da ys: 9: 0 0-2 0: 0 0 (e xcl u di n g h oli da y s)
T E L
（Pfizer e xcl usi ve li ne ）
E- mail a d dress
ja pa n hel p des k @ m ds ol.c o m
1 7. R E F E R E N C E S
N ot ap plica ble
1 8. LI S T O F T A B L E S 
T a ble 1 Varia bles a n d sc he d ule of o bser vati o n
1 9. LI S T O F FI G U R E S
N ot a p plic a bl e
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 pl ica 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
N ot A p plica ble
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)
P P D

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
P a ge 1 of 1
D oc u me nt T y pe
Pr ot oc ol
D oc u me nt D ate 
( Ori gi n al)
1 8 Oct o ber 2 0 2 2
Pr o gr a m
B 5 3 7
St u d y
B 5 3 7 1 0 0 6
Ori gi n al L a n g u a ge
Ja pa nase
Site
N A
Tr a nsl ati o n L a n g u a ge
E n glis h
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
I nter nal Pfizer e m pl o yee
Tr a nsl ati o n Ve n d or 
N/ A
Tr a nsl at or N a m e
D ate of Tr a nsl ati o n
1 6 Dece m ber 2 0 2 2
Re vie wer N a m e
D ate of Re vie w
1 1 Ja n uar y 2 0 2 3
0 9 0 1 7 7 e 1 9 c 4 4 3 c 2 9\ A p pr o v e d\ A p pr o v e d O n: 1 2- J a n- 2 0 2 3 0 5: 0 1 ( G M T)
P P D
P P D