Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)
Conditions: Hematologic Malignancy
Sponsor: Pfizer

BESPONSA® (Inotuzumab Ozogamycin)
<B1931027> NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 4, 07 Nov 2023
PFIZER CONFIDENTIAL
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023
Page 1 of 37
NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study information
Title
Korean Post Marketing Surveillance study to 
observe safety and effectiveness of 
BESPONSA®
Protocol number
B1931027
Protocol version identifier
Amendment 4
Date of last version of protocol
07 Nov 2023
Active substance
Inotuzumab ozogamycin (L01XC26)
Medicinal product
BESPONSA® Injection
Research question and objectives
The objective of this study is to monitor 
usage of BESPONSA® in real practice 
including adverse events on BESPONSA®.
Author
Pfizer Pharmaceuticals Korea Ltd.
Seoul, Korea, Republic of
This document contains confidential information belonging to Pfizer.  Except as otherwise agreed to in 
writing, by accepting or reviewing this document, you agree to hold this information in confidence and not 
copy or disclose it to others (except where required by applicable law) or use it for unauthorized purposes.  In 
the event of any actual or suspected breach of this obligation, Pfizer must be promptly notified.
090177e19f6533ee\Final\Final On: 07-Dec-2023 08:19 (GMT)
PPD

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2  of 3 7  
T A B L E O F C O N T E N T S  
T A B L E O F C O N T E N T S  .......................................................................................................... 2  
1.  LI S T O F A B B R E VI A TI O N S  ............................................................................................... 4  
2 . R E S P O N SI B L E P A R TI E S  ................................................................................................... 6  
3.  A M E N D M E N T S A N D U P D A T E S  ...................................................................................... 7  
4. MI L E S T O N E S  ...................................................................................................................... 9  
5.  R A T I O N A L E A N D B A C K G R O U N D ............................................................................... 1 0  
6. R E S E A R C H Q U E S TI O N A N D O BJ E C TI V E S  ................................................................ 1 1  
7. R E S E A R C H M E T H O D S  ................................................................................................... 1 1  
7. 1.  St u d y desi g n  ........................................................................................................... 1 1  
7. 2.  Setti n g  ..................................................................................................................... 1 1  
7. 2. 1.  I n cl usi o n criteria ........................................................................................ 1 1  
7. 2. 2.  E xcl usi o n criteria  ....................................................................................... 1 2  
7. 2. 3.  D urati o n of t he st u d y  ................................................................................. 1 2  
7. 2. 4.  D osa ge a n d a d mi nistra ti o n ........................................................................ 1 2  
7. 3.  St u d y Pr oce d ures  .................................................................................................... 1 3  
7. 3. 1.  Inf or mati o n  of i nstit uti o n  ........................................................................... 1 3  
7. 3 . 2. S ubject i nf or mati o n ................................................................................... 1 3  
7. 3. 3.  Pri or treat me nt hist or y of B-cell prec urs or l y m p h o blastic le u ke mia  ......... 1 4  
7. 3. 4. Me dical Hist or y  ......................................................................................... 1 4  
7. 3. 5. C o nc o mita nt Me dicati o n  ........................................................................... 1 5  
7. 3. 6. A d mi nistrati o n  stat us a n d res p o nse  e val uati o n f or eac h c y cle of  
B E S P O N S A ®  .................................................................................................. 1 5  
7. 3. 7.  Fi nal e ffecti ve n ess e val uati o n  .................................................................... 1 6  
7. 3. 8.  Safet y E val uati o n  ....................................................................................... 1 6  
7. 4.  St u d y  Size  ............................................................................................................... 2 2  
7. 5. Data S o urces  ........................................................................................................... 2 2  
7. 6.  Data ma na g e me nt  ................................................................................................... 2 2  
7. 6. 1. Cas e re p ort f or ms ( C R Fs)/ Data c ollecti o n t o ols ( D C Ts)/ Electr o nic d ata 
rec or d .............................................................................................................. 2 2  
7. 6. 2. Rec or d rete nti o n  ......................................................................................... 2 3  
7 . 7. Data  a n al ysi s........................................................................................................... 2 4  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3  of 3 7  
7. 7. 1.  Safet y anal ysis  ........................................................................................... 2 4  
7. 7. 2. Effecti ve n ess a nal ysis  ................................................................................ 2 4  
7 . 7. 3. I nt eri m A nal ysis ......................................................................................... 2 5  
7. 8.  Q ualit y c o ntr ol  ........................................................................................................ 2 5  
7. 9. Li mitati o ns  of t he researc h m et h o ds  ...................................................................... 2 5  
8. P R O T E C TI O N O F H U M A N S U BJ E C T S  ......................................................................... 2 5  
8. 1. Patie nt i nf or mati o n  ................................................................................................. 2 5  
8. 2. Patie nt c o nse nt  ........................................................................................................ 2 6  
8. 3. Patie nt wit h dra wal  .................................................................................................. 2 7  
8. 4. I nstit uti o nal Re vie w B oar d (I R B)/I n de p e n de nt Et hics C o m mittee (I E C) .............. 2 7  
8. 5. Et hical C o n d uct of t he St u d y .................................................................................. 2 7  
9.  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 8  
9. 1. Re q uire me nts  .......................................................................................................... 2 8  
9. 2. Re p orti n g peri o d  ..................................................................................................... 2 9  
9. 3. Ca usalit y assess me nt  .............................................................................................. 2 9  
9. 4.  Defi niti o ns of Safet y E ve nts ................................................................................... 3 0  
9. 4. 1. A d verse e ve nts  ........................................................................................... 3 0  
9. 4. 2. Seri o us a d verse e v e nts  ............................................................................... 3 0  
9. 5. Si n gle refere nce s afet y d oc u me nt  ........................................................................... 3 3  
1 0.  P L A N S F O R  DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S  ....... 3 4  
C O M M U NI C A TI O N O F I S S U E S  ......................................................................................... 3 4  
1 1. P U B LI C A TI O N O F S T U D Y R E S U L T S  ......................................................................... 3 4  
1 2.  R E F E R E N C E S  ................................................................................................................. 3 5  
A P P E N DI C E S  ........................................................................................................................ 3 6  
A P P E N DI X 1. R E S P O N S E C RI T E RI A  ................................................................................ 3 6  
A P P E N DI X 1. R E S P O N S E C RI T E RI A  ................................................................................ 3 7  
 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 4  of 3 7  
1.  LI S T O F A B B R E VI A TI O N S  
A b bre vi ati o n  
Defi niti o n  
A E  
A d verse E ve nt  
A E M  
A d verse E ve nt M o nit ori n g  
A L L  
Ac ute L y m p h o blastic Le u ke mia  
A N C  
A bs ol ute Ne utr o p hil C o u nt  
A D L  
Acti vities of Dail y L i vi n g 
B S A  
B o d y S urface  Area  
CI  
C o nfi de nce I nter val  
C R  
C o m plete res p o nse / C o m plete re missi o n  
C R F  
Case Re p ort F or m  
C Ri  
C o m plete res p o nse wit h i nc o m plete bl o o d c o u n t rec o ver y 
/ C o m plete re missi o n wit h i nc o m plete he mat ol o gic rec o ver y 
C T C A E  
C o m m o n Ter mi n o l o g y Criteria f or A d ver se E ve nts 
H C T  
He mat o p oietic Cell Tra ns pla nt  
I E C 
I n de pe n de nt Et hics C o m mittee  
I g G 4 
I m m u n o gl o b uli n t y pe G, s u bt y pe 4 
I R B 
I nstit uti o nal Re view B oar d  
M F D S  
Mi nistr y of F o o d a n d Dr u g Safet y  
N CI  
Nati o nal Ca ncer I nstit ute  
NI  
N o n -Inter ve nt i o nal 
NI S  
N o n -I nter ve nti o nal St u d y  
P M S  
P ost -Mar keti n g S ur veilla nce  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)
C CI

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 5  of 3 7  
R M P  
Ris k Ma na ge me nt Pla n  
S A E  
Seri o us A d verse E ve nt  
S A P  
Statistical A nal ysis Pla n  
S R S D  
Si n gle Refere nce Safet y D oc u me nt  
V O D/ S O S  
Ve n o -Occl usi ve li ver Disease/ Si n us oi dal O b str ucti on S y n dr o m e  
 
 
 
 
 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 6  of 3 7  
2.  R E S P O N SI B L E P A R TI E S  
Pri nci p al I n vesti g at or (s) of t he Pr ot oc ol  
N a m e, de gree(s)  
Title  
Affili ati o n  
A d dress  
J u-W o n W o o, B. P har m, 
M B A  
N o n -I nter ve nti o nal 
St u d y Lea d  
Pfizer P har mace utic als 
K orea Lt d  
Se o ul, K orea  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 7  of 3 7  
3.  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 be r 
D ate  
Pr ot oc ol 
secti o n(s) 
c h a n ge d  
S u m m ar y of a me n d me nt(s)  
Re as o n  
A me n d me nt 
1  
1 3 N o v  
2 0 1 8  
2. Res p o nsi ble 
p arties 
C ha n ge of Pri nci p al 
I n vesti gat or(s) of t he Pr ot oc ol 
Resi g nati o n of res p o nsi ble c olle ag ue  
7. 3. 8. 3. A d verse 
e ve nts data 
c ollecti o n 
C ha n ge of c ate g ory  f or 
acti o n/ o utc o me  
Ali g n wit h A E M 0 1 - F or m g ui d a nce - NI S 
WI T H Sti p ul ate d C ollecti o n of 
A Es/ Pr a g m atic N o n -Me dici n al I nter v St u dy 
C o m pleti o n G ui de ( V 6: A u g -2 0 1 6)  
7. 4. Sa m ple size  
Descri pti o n t he Secti o n of 
Re g ulati o n o n A p pr o val a n d 
Re vie w of Bi o l o gical Pr o d ucts  
a n d re -state t he refere nce f or 
sa m ple size 
Descri be rele va nt la w i n detail  a n d state m ore 
pr o per refere nce f or sa m ple siz e 
7. 5. Data s o urce  
7. 5. 2 Rec or d 
rete nti o n 
7. 6. 1 C R Fs/ D C Ts 
/ Electr o nic data 
rec or d 
8. Pr otecti o n of 
h u ma n s u bjects  
De lete du plicate d secti o n  a n d 
m o ve s o me secti o n t o 7. 6. 1  
 
M o ve t o 7. 6. 2  
 
 
A d d data ma na ge me nt secti o n  
 
 
 
R e-state i n detail 
Ali g n wit h C T 2 4 -WI -G L 0 2 -R F 0 1 1. 0 N o n -
I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or 
Pri mar y Data C ollecti o n St u d y  1 5 -A u g -2 0 1 8  
A me n d me nt
2  
2 7 Ma r2
0 1 9  
4. Milest o nes  
C ha n ge of P la n ne d date f or 
milest o nes  
C ha n ge of P la n ne d date acc or di n g t o t he 
act ual date of B E S P O N S A®  ap pr o val . 
7. 2. 3. D urati o n of 
t he st u d y 
A d d defi niti o n i n t he d urati o n 
of t he st u d y  
D ue t o M F D S c orrecti ve or der  
A me n d me nt
3  
1 9 J u n  
2 0 2 3  
2. Res p o nsi ble 
p arties 
C ha n ge of Pri nci pal 
I n vesti gat or(s) of t he Pr ot oc ol 
Resi g nati o n of res p o nsi ble c olle ag ue  
5 . Rati o nale a n d 
bac k gr o u n d  
C ha n ge of t he n u m ber of 
s u bjects 
U p date res ult of P hase 3 I N O -
V A T E  st u d y 
C ha n ges base d o n t he a dj ust me nt a p p licati o n 
f or t he n u m ber of s u bjects 
T o reflect fi nal res ult  
7 . 2. 3. D urati o n of 
t he st u d y 
C ha n ge of t he n u m ber  of 
s u bjects 
C ha n ges base d o n t he a dj ust me nt a p plicati o n 
f or t he n u m ber of s u bjects 
7 . 4. St u d y Size  
C ha n ge of t he n u m ber of 
s u bjects 
C h a n ges b ase d o n t he a dj ust me nt a p plicati o n 
f or t he n u m ber of s u bjects 
A me n d me nt
4  
0 7  N o v  
2 0 2 3  
5 . Rati o nale a n d 
bac k gr o u n d  
C ha n ge of t he n u m ber  of 
s u bjects 
C ha n ges base d o n t he a dj ust me nt a p plicati o n 
f or t he n u m ber of s u bjects 
7 . 2. 3. D urati o n of 
t he st u d y 
C ha n ge  of t he n u m ber  of 
s u bjects 
C ha n ges base d o n t he a dj ust me nt a p plicati o n 
f or t he n u m ber of s u bjects 
7. 3. 8. 2. Defi niti o n 
of seri o us a d verse 
e ve nts ( S A Es) 
Re visi o n  of descri pti o n f or 
H os pitalizati o n  
Reflecti o n 
of t he 
u p date d 
Pfizer 
S O P 
te m plate 
7 .4. St u d y Size  
C ha n ge of t he n u m ber of 
s u bjects 
C ha n ges base d o n t he a dj ust me nt a p plicati o n 
f or t he n u m ber of s u bjects 
7. 6. 2. Rec or d 
C ha n ges of rec or d rete nti o n 
Reflecti o n 
of t he 
u p date d 
Pfizer 
S O P 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 8  of 3 7  
rete nti o n 
peri o d  
te m plate 
9 . 4. 3. S ce nari o s 
necessitat i n g 
re porti n g t o Pfizer 
Safet y wit hi n 2 4 
h o urs  
Re visi o n  of descri pti o n f or 
E x p os ure d uri n g pre g na nc y  
Reflecti o n 
of t he 
u p date d 
Pfizer 
S O P 
te m plate 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 9  of 3 7  
4.  MI L E S T O N E S   
Milest o ne  
Pl a n ne d d ate  
B E S P O N S A ®  ap pr o val  
 3 J a n 2 0 1 9 
Start o f data c ollecti o n  
 1 J u n 2 0 1 9  
E n d of d ata c ollecti o n  
 2 Ja n 2 0 2 5  
I nteri m re p ort  
As re q uire d b y  M F D S re g ulati o ns , t he peri o dic 
i nteri m re p ort al o n g wit h R M P re p ort  w o ul d  be 
s u b mitte d t o M F D S e ver y 6 m o nt hs f or t he first t w o 
years a n d t h e n a n n ual r e p ort  w o ul d  b e s u b mitte d t o 
M F D S f or t he t hird, f o urt h  a n d fift h  year . T he fi n al 
re p ort w o ul d  be s u b m itte d i n t he si xt h y ear refer t o 
R M P milest o ne .  
 2 Se p 2 0 1 9  
 2 Mar 2 0 2 0  
 2 Se p 2 0 2 0  
 2 Mar 2 0 2 1  
 2 Mar 2 0 2 2  
 2 Mar 2 0 2 3  
 2 Mar 2 0 2 4  
M F D S re -e xa mi nati o n re p ort  
 2 A pr 2 0 2 5  
 
 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 0  of 3 7  
5.  R A TI O N A L E A N D B A C K G R O U N D  
A c ute l y m p h o blastic leu ke mia ( A L L ) is a rare, serio us, a n d  life-threate ni n g co n diti o n w it h a 
n ee d f or im pr o v e d  thera pies . Rela pse d or refract or y B -cell A L L is a fatal disease wit h a 
me di a n s ur vi val ti me i n a d ults of o nl y a p pr o xi matel y 3 -6 m o nt hs 1  2. T he a ge a dj uste d  
i nci de nce rate of A L L i n t he U nite d Sta tes is 1. 7 per 1 0 0, 0 0 0 i n di vi d uals per  y ear 3, wit h 
a p pr o xi matel y 6, 0 2 0 n e w cases a n d 1, 4 4 0 deat hs esti mate d i n 2 0 1 4 4. W hile t he c ure rat es a n d 
s ur vival o utc o mes f or  B -cell A L L ha ve i m pr o ve d d uri n g  t he last se veral deca des, m ost of t he 
i m pr o ve me nts ha ve occurre d i n y o u n ger pati e nt s, pri maril y a m o n g c hil dre n. 
R ece nt 
i m pr o ve me nts are lar gel y d ue t o a d va nces i n t he u n dersta n di n g of t he m olec ul ar ge n etics a n d 
pat h o ge nesis  of B -cell A L L, i nc or p orati o n of  ris k-a da pte d t hera p y a n d  t he a dve nt of tar gete d 
a ge nts.  
Bef ore t he a p pr o val of  B E S P O N S A ®  i n K orea, this n o n -i nter ve nti o nal st ud y is desi g nate d  as 
a P ost -Mar keti n g S ur veilla nce ( P M S) St u d y a n d is a c o m mit m e nt t o Mi nistr y of F o o d a n d 
Dr u g Safet y ( M F D S), as a part of Ri s k Ma na ge me nt Pla n ( R M P) w hic h is r e q uire d b y M F D S. 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)
C CI

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 1  of 3 7  
T he safet y a n d effect i ve ness i nfor mati o n of B E S P O N S A ®  will  be g at here d  at mi ni m u m 1 0 0  
s u bjects a d mi nistere d i n t he setti n g of r o uti ne practice i n K orea d uri n g t he i nitial  6 years after 
t he a p pr o val.  
 
6.  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 he o bjecti ves of t his st u d y are t o deter mi ne a n y pr o b le ms or q uesti o ns ass ociate d wit h 
B E S P O N S A ®  after mar keti n g, wit h re gar d t o t he f oll o wi n g cla uses u n der c o n diti o ns of 
ge neral cli nical practice, i n c o m plia nce wit h t he re g ulati o n “ Re -e xa mi nati o n G ui deli ne of 
N e w D r u gs, Etc” (Mi nistr y of F o o d a n d Dr u g Safet y  N otificati o n 2 0 1 5 -7 9, 2 0 1 5. 1 0. 3 0, 
a me n de d).  
( 1) Seri o us a d verse e ve nt/a d vers e dr u g reacti o n  
( 2) U ne x pect e d  a d vers e e ve nt/a d verse dr u g reacti o n t hat has n ot bee n reflect e d i n t he 
a p pr o ve d dr u g l a bel.  
( 3) K n o w n a d verse dr u g reacti o n  
( 4) N o n -seri o us a d v erse dr u g reacti o n  
( 5) Ot her safet y a n d effecti ve ness i nf or mati o n  
 
7.  R E S E A R C H M E T H O D S  
7. 1.  St u d y d esi g n   
T his is a  p r os pecti ve, o bser vati o nal, n o n-i nter ve nti o nal, m ulti -ce nter st u d y i n w hic h s u bjects 
will be a d mi nistere d as part of r o uti ne pra ctice at K orea n h e alt h care ce nters b y accre dite d 
p h ysicia ns. T he st u d y ca n be p erf or me d i n K orea n healt h care ce nters w here B E S P O N S A ®  is 
prescri be d t o treat t he rel a pse d or refract or y B-cell prec urs or A L L.  
  
7. 2.  Setti n g  
All s u bjects e nr olle d s h o ul d meet t he us ual  prescri bi n g criteria f or B E S P O N S A ®  as p er t he 
local  p r o d uct d oc u me nt  ( L P D) a n d s h o ul d be e n tere d i nt o t he st u d y at t he p hysicia n ’s 
discreti o n.  
7. 2. 1.  I ncl usi o n criteri a 
Patie nts  m ust meet al l of t he f oll o wi n g i ncl usi o n criteri a t o b e eli gi ble f or i ncl usi o n i n t he 
st u d y: 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 2  of 3 7  
1.  Pati ents dia g n ose d  as rela pse d or  refract or y B-cell prec urs or l y m p h o blastic le u ke mia 
( A L L). 
2.  E vi de nce of a pers o na ll y si g ne d a n d date d i nf or me d c o nse nt d oc u m e nt i n dicati n g t hat t he 
pati e nt ( or a le g all y acce pta ble re prese nt ati ve) h as bee n i nf o r me d of all p erti n ent as pects 
of t he st u d y . 
 
7. 2. 2.  E x cl usi o n criteri a  
Patie nt s meeti n g  a n y of t he f oll o wi n g criteria will n ot be i ncl u de d i n t he st u d y:  
1.  A n y patie nts w h o d oes n ot a gree t hat Pfizer  a n d c o m p a nies w or ki n g wit h Pfizer use 
his/ her i nf or mati o n . 
2.  Patie nt s t o w h o m B E S P O N S A ®  is c o ntrai n di cate d as per t he l ocal la beli n g . 
 
7. 2. 3.  D ur ati o n of t he st u d y  
Acc or di n g t o M F D S re -e xa mi nati o n re g ul ati o n, t he re-e xa mi nati o n re p ort base d o n c ollecte d 
data of 6 y ears m us t be s u b mitte d t o M F D S wit hi n 3 m o nt hs after t he e n d of s p ecifie d re -
e xa mi nati o n peri o d (fr o m t he pr o d uct a p pr o val date t o 6 years after war ds).  
T he data c ollecti o n peri o d of t his st u d y  is u ntil t he re q uire d s u bject n u m ber ( 1 0 0  patie nts) is  
c ollecte d. T h e o bser vati o n peri o d f or eac h s u bject is fr o m i nitiati n g a d mi ni strati o n of first 
d ose of B E S P O N S A ®  to t he e n d of t h e o bse r vati o n peri o d of t he st u d y, w hi c h  m ust i ncl u de at 
least 2 8 cale n dar da ys f oll o wi n g t he last a d mi nistrati o n of a B E S P O N S A ® . I n case of patie nt 
t hat He mat o p oietic Ste m Cell Tra ns pl a nt ( H S C T) after a dmi nistrate d B E S P O N S A ®, f oll o w -
u p u ntil 1 8 0  da ys after tra n s pla ntati o n. All t he data c ollecte d d uri n g t he o bser vati o n peri o d 
s h o ul d be rec or de d i n t h e case re p ort f or m ( C R F). I n cas e of a n a d verse e ve nt/safet y e ve nt 
rec o g niz e d after t he o bser vati o n perio d e n ds, it s h o ul d b e rec or de d i n the C R F as s pecifie d i n 
Sect i o n 7 . 
 
7. 2. 4.  D os a ge a n d a d mi nistr ati o n  
T he use a n d d osa g e rec o m me n dati o ns f or  B E S P O N S A ®  s h o ul d ta ke place o n t he basis of t he 
a p pr o ve d L P D . If s u bjects ha ve bee n a d mi nistere d B E S P O N S A ®  off la bel, t hey  s ho ul d be 
e xcl u de d fr o m t he safet y a nal ysis set a n d a nal y ze d se parat el y. 
Refer t o t he m ost  u p d ate d L P D  f or t he detaile d i nf or mati o n o n prescri pti o n.   
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 3  of 3 7  
7. 3.  St u d y Pr oce d ures  
7. 3. 1.  Inf or m ati o n  of i nsti t uti o n 
T he  f oll o wi n g will be rec or de d i n t he C R F f or eac h patie nt: 
•  C R F n u m ber ( Patie nt n u m ber):  T he i n vesti gat or will se q ue ntiall y assi g n eac h patie nt 
a patie nt i d e ntificati o n n u m ber, w hic h will be a 4 -di git n u m ber.  It will be c o m bi ne d 
wit h c o de n u m ber of  i nstit utio n b y s p o ns or.  
•  Na me  of i nstit uti o n  
•  Na me of de p art me nt  
•  Na m e of i n vesti gat or 
•  Da te of si g ni n g data pri v ac y  state me nt 
•  C o nfi r mati o n of Data Pri vac y State me nt: If all a gree me nt f or usi n g s u bject ’s pers o nal 
a n d me dical i nf or mati o n, si g nat ure a n d d ate ar e o btai n e d  b y s u bject or le gall y 
a ut h orize d re pres e ntati v e, t he n c h ec k t he b o x of “y es”. If n ot, c h ec k “n o ” w hic h  
mea ns t hat cas e  is e xcl u d e d fr o m t his st u d y.  
•  C o n firmati o n of pr o per s u bject e nr o ll me nt: If S u bjects ca n be e nr olle d wit h sa tisf yi n g 
t he i ncl usi o n criteria, t he n c hec k t he b o x of “y es ”. If n ot, c hec k “n o ” w hic h me a ns 
t hat case is e x cl u de d fr o m t his st u d y.   
•  Si g nat ure of in vesti gat or : C o ntracte d i n vesti gator  m ust si g n after i de ntif yi n g t he C R F.  
 
7. 3. 2.  S u bject i nf or m ati o n 
•  Date of birt h  
•  Ge n der  
•  Hei g ht/ Wei g ht  
•  P re g nanc y : If ‘ yes’, t h e n rec or d t h e wee k of pre g n a nc y. 
•  Breast -fee di n g 
•  Dia g n osis : S elect o ne a m o n g ‘P hila del p hia ( +) B -cell A L L ’, ‘P hila del p hia (-) B -cell 
A L L ’, or ‘U n k n o w n ’. 
•  First Dia g n osis date / First treat me nt date: Rec or d  a p pr o xi mate date if a n act u al date is  
u n k n o w n.  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 4  of 3 7  
•  C urre nt disease stat us : S elect eit her ‘refract or y’ or ‘rel a pse d’. If ‘rela pse d’, select o ne 
am o n g ‘first relaps e d ’, ‘sec o n d rela psed ’, or ‘t hird or m ore  rela psed ’.  Rec or d t h e  
date of eac h o nset. Rec or d a p pr o xi mate date if a n act ual dat e is u n k n o w n.  
 
7. 3. 3.  Pri or tre at me nt hist or y of B-cell prec urs o r l y m p h o bl asti c le u ke mi a 
Pri or  t o a d mi nistrati n g B E S P O N S A ® , if t he s u bject recei ve d s yst e mic t hera p y or 
he mat o p oietic cell tra ns pla nt ( H C T ) t o treat B -cell prec urs or l y m p h o blastic le u ke mia, rec or d 
t he m. First, c hec k a m o n g ‘yes ’, ‘n o ’ or ‘u n k n o w n ’. If ‘yes ’, rec or d the f oll o wi n gs.  
 
7. 3. 3. 1.  Pr ev i o us s yste mic t her a p y 
•  Re g i me n: Rec or d t he  na me of re gi me n.  
•  P ur p ose  of tr eat me nt : Select o ne a m o n g ‘i n d ucti on ’, ‘c o ns oli dati o n ’, ‘mai nte na nce ’, 
‘c o n diti o ni n g ’, or ‘i nte nsificati o n’. 
•  Na me of tr eat me nt dr u g : Rec or d ge n eric na m e.  
•  D urati o n  of a d mi nistrati o n : R ec or d t he start dat e a n d st o p dat e. Rec or d a p pr o xi mate 
date if a n act ual da te is u n k n o w n. 
•  Best res p o nse t o t hera p y: First, c h ec k a m o n g ‘c o n d uct e d ’, ‘n o t c o n d ucte d’ or 
‘u n k n o w n ’. If ‘c o n d uct e d ’, rec or d t he dat e of e val uati o n a n d select o ne a m o n g 
‘c o m plete res p o nse ( C R) ’, ‘C R wit h i nc o m pl ete bl o o d c o u nt rec o ver y ( C Ri) ’, 
‘refract or y dise ase ’, or ‘pr o gressi ve disea s e’. Res p o nse C riteria is defi ne d  acc or di n g 
t o ‘N C C N G ui deli n e V ersi o n 2. 2 0 1 6 Ac ut e Ly m p h o bl astic Le uke mi a 9’. Refer t o 
A p pe n di x 1 f o r det aile d R es p on se C riteria. 
 
7. 3. 3. 2.  Pre vi o us He m at o p oietic cell  tr a ns pl a nt 
•  Date of H C T : Rec or d a p pr o xi mate date if a n act u al date  is u n k n o w n. 
•  Best res p o nse t o t hera p y : First, c h ec k a m o n g ‘c on d uct e d ’, ‘n o t c o n d ucte d’ or 
‘u n k n o w n ’. If ‘c o n d ucte d ’, rec or d t he date  of e val uati o n a n d select o ne a m o n g ‘C R ’, 
‘C Ri ’, ‘refract or y disease’, or ‘pr o gressi ve disea s e’.  
 
7. 3. 4.  Me dic al Hist or y  
Select a m o n g ‘ yes’ or ‘ n o’ f or me dical hist or y of f oll o wi n gs. Past or  prese nt d isease will be 
deter mi ne d bas e d o n t he  first B E S P O N S A ®  a dmi ni strati o n date.  R ec or d a de q uate f ull na me 
of t he dis ease d o w n as t he Me dical Ter mi n ol o g y Dic ti o nar y i n dicates ( writte n b y K orea n 
Me dical S ociet y).  
 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 5  of 3 7  
7. 3. 4. 1.  He p atic dis or der  / Re n al dis or der  
If ‘ yes’, rec or d t he na m e of t he  disease, s e verit y a n d stat us. 
E ver y s u bject 
m ust be e val u at e d 
w het her he/s he ha s ever ha d ve n o occl usi ve li ver 
disease/si n us oi dal o bs tr ucti o n s y n dr o me ( V O D/ S O S). If he/s he h as , c hec k ‘yes ’ a n d s elect 
se verit y. C hec k ‘n o ’ if he/s he ha d ne ver ha d.  
 
7. 3. 4. 2.  Aller gic hist or y  
If ‘ yes’, rec or d t he aller gen  a nd stat us . 
 
7. 3. 4. 3.  Ot her  dise ases / s y m pt o ms  
If ‘ yes’, rec or d t he na m e of t he  disease a n d stat us. 
 
7. 3. 5.  C o nc o mit a nt Me dic ati o n  
Rec or d t h e c o n c o mita nt me dicati o n i ncl u di n g t he tra nsf usi o n w hile  B E S P O N S A ®  is bei n g 
a d mi nistrate d. First select eit her ‘ yes’ or ‘ n o’ t hen re c or d i n m or e det ails if selecte d ‘ yes’. 
•  
Na me of me dicati o n : Rec or d ge neric na m e.  
•  
Treat me nt s tart dat e 
•  
Treat me nt st o p date : If t he treat me nt is n ot ter mi nate d u ntil t he ti mi n g of C R F 
c o mpleti o n, lea ve it bla n k . 
•  
O n g oi n g : If t he treat me nt is n ot ter mi nated u n til t he ti mi n g of C R F c o m pleti o n, 
c hec k ‘ on g oi n g’.  
•  
P ur p ose  of treat me nt : Select  o ne a m o n g ‘t reat me nt f or B -cell A L L ’, ‘treatme nt f or 
ot her diseases ’, ‘treat me nt f or a n a d verse e v e nt’, ‘pre ve nti o n  of dr u g si de effect’, or 
‘ ot her’. If ‘ ot her’, rec or d t he s pecific reas o n.  
7. 3. 6.  A d m i nistr atio n  st at us a n d re s p o nse e v al u ati o n f or e ac h c y cle of  B E S P O N S A ®  
Rec o r d t he f oll o wi n g wit h re gar d t o a d mi nistrati ve stat us a n d res p o nse e val uati o n f or eac h 
c ycle. R ec or d a d mi nistrati ve stat us of all c ycle u ntil t he last a d mi nistr ati on d ose . Refer t o  
L P D f or p os ol o g y a n d met h o d of a d mi nistra ti o n. 
•  A d mi nistrati o n date  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 6  of 3 7  
•  B o d y s ur face area 
•  A d mi nistrati o n d ose  
•  Pr e-me dicati o n:  If ‘c o n d ucte d’, rec or d t he detaile d i nf or mati o n  i n ‘4. C o n c o mita nt 
me dicati o n ’ cla us e i n C R F. 
•  Res p o nse e val u ati o n a fter eac h c y cle : Reco r d t he e val uati o n date a nd res p o nse . Sele ct 
o ne a m o n g ‘C R ’, ‘C Ri ’, ‘refractor y dise ase ’, ‘pr o gressi ve disea s e’, or ‘rela pse d 
disease ’. Res p o ns e C riteria is defi ne d  acc or di n g t o ‘N C C N G ui deli ne Versi o n 2. 2 0 1 6 
Ac ute Ly m p h o bl astic Le uke mi a 9’. Refer t o A p pe n d ix 1 f or detaile d R es p o ns e C riteria. 
If res p o ns e e val u ati o n is n ot d o ne, c hec k ‘u n d o ne ’ a n d lea ve t he e val ua ti o n date 
bla n k.   
 
7. 3. 7.  Fi n al effecti v e ness e v al u ati o n   
Rec or d t h e fi nal effecti ve ness after all c ycle of B E S P O N S A ®  is fi nis he d.  
C h ec k ‘c o n d uct e d ’ if final effecti ve ness is e val uate d t he n rec or d t he date of  e val uati o n. 
C hec k  ‘n o t c o n d ucte d’ if fi nal effecti veness is n ot e val uate d t he n sele ct o ne reas o n w h y it is 
n ot c o n d ucte d  a mo n g ‘deat h ’, ‘f oll o w u p l oss’, or ‘ot her ’. If ‘ ot her’, rec or d  t he s p ecific 
reas o n. 
•  Res p o nse criteria: S ele ct o ne a m o n g ‘C R ’, ‘C Ri ’, ‘refract or y disease’, ‘pr o gressi ve 
disease ’, or ‘Rela pse d dis ease ’.  
•  Pla n f or H C T : C hec k  ‘ yes’ if H C T is o n pla n or o n o n g oin g f or a s u bject.  
 
7. 3. 8.  S afet y E v al u ati o n  
Safet y will be asses s e d b ase d o n a d v erse  e ve nts re p orte d f or all  p atie nts w h o rece i ve d at least 
o ne d ose of B E S P O N S A ®  a n d c o m plete d safet y f oll o w -u p . E ver y o bser ve d a n d re p orte d 
a d verse e ve nt, re gar dless of t h e ca usal r elati o ns hi p wit h t he st u d y dr u g, m ust be rec or de d o n a n 
safet y e val uati o n  secti o n i n C R F  
7. 3. 8. 1.  Defi niti o n of a d verse e v e nts  
A n a d verse e ve nt ( A E ) is a n y u nt o war d me dical occ urre nce i n a patient a d mi nistere d a 
me dici nal pr o d uct.  T h e e ve nt n ee d n ot nece ssaril y have a ca usal rel ati o ns hi p wit h t he 
pr o d uct treat me nt or us a ge.  E xa m ples of a dv erse e ve nt s i ncl u de b ut are n ot li mite d to:   
•  A b n or mal test fi n di n gs (see b el o w f or cir c 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 ni fica nt s y mpt o ms a n d si g ns;  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 7  of 3 7  
•  C ha n ges i n p h ysical e xa mi nati o n fi n di n gs ; 
•  H y perse nsiti vit y;  
•  P r o gressi o n/ w orse ni n g of un derl yi n g diseas e;  
•  Lac k of effic ac y;  
•  Dr u g a b use;   
•  Dr u g de pe n d e 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 s y m pt oms res ulti n g fr o m:  
•  Dr u g o ver d os e;  
•  Dr u g wit h dra w al;  
•  Dr u g mis use;  
•  Of f-lab el use;  
•  Dr u g i n teracti o ns; 
•  E xtra vasati o n ; 
•  E x p os ure d uri n g pre g na n c y;  
•  E x p os ure d uri n g breas t f ee di n g; 
•  Me dicati o n err or;  
•  Occ u pati o nal e x p os ure.  
A b n or mal test fi n di n gs  
T he criteria f or d eter mi ni n g  w het her a n a b n or mal o bjecti ve test fi n di n g s h o ul d be re p orte d as 
a n a d vers e ev e nt  are as f oll o ws:  
•  Tes t res ult is ass ociate d wit h acc o m pa n yi n g s y m pt o ms,  a n d/ or 
•  Test res ult re q uires a d d iti 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 
•  Tes t 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 onc o mita nt dr u g t reat me nt, or ot her t hera p y, a n d/ or 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 8  of 3 7  
•  Test res ult is c o nsi dere d t o be  a n a d v erse e ve nt  b y t he i n vesti gat or or s p o ns or.  
Merel y re pe ati n g a n a b n or mal test, i n t he a bs e nce of a n y of t h e a b o v e c o n diti o ns, d oes n ot 
c o nstit u te a n a d verse e ve nt .  A n y a b n or m al test r es 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 d verse e ve nt.  
 
7. 3. 8. 2.  Defi niti o n of s eri o us a d verse e v e nts ( S A Es)  
A se ri o us a d v erse e ve nt is a n y u nt o war d me dical occ urre n ce i n a patie nt a d mi niste re d a 
me dici nal or n utriti o nal pr o d uct  (i ncl u di n g pe diatri c f or m ulas) at a n y  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 o f h os pitalizati o n (see bel o w f or 
circ u msta nces t hat d o n o t c onstit ute a d verse e ve nt s); 
•  Res ults i n persi ste 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 m al y/ birt h defect ; 
Pr o gressi o n of t he mali g na nc y u n der st u d y (i ncl u d i n g si g ns a n d s y m pt om s of pr o gressi o n) 
s h o ul d n ot be re p orte d as a seri o us a d verse e ve nt u nless t he o ut c o me is fatal wit hi n t he 
safet y re p orti n g peri o d. H os pitalizati o n d ue t o si g ns a n d s y mpt o ms of d isease pr o gressi o n 
s h o ul d n ot be re p orte d as a seri o us a dvers e e v e nt. If  t he m ali g na nc y has a fatal o ut c o me 
d uri n g t he st u d y or wit hi n t he safet y re p ortin g peri o d, t he n t he e ve nt lea di n g t o deat h m ust 
be rec or de d as a n a d v ers e e ve nt a n d as a seri o us a d vers e e v e nt wit h se verit y Gra de 5.  
Me dical a n d scie ntific j u d g me nt is e xercise d in deter mi ni n g w het her a n e v e nt is a n i m p o rta nt 
me dical e ve nt.  A n i m p orta nt  me dical e ve nt ma y n ot be i m me di atel 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 wever, 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 qu ire i nter ve nti o n t o pre vent o ne of t he ot her o utc o mes liste d i n t he 
defi nit i o n a b o ve, t he i m p orta nt me dical e v e nt s h o ul d be re p orte d as seri o us.  
E xa m ples of s uc h e v e nts  are i nte n si ve tr eat me nt i n a n e mer ge n c y r o o m or at h o me f or 
aller gic br o nc h os pas m; bl oo d d yscrasias or c o n v ulsi o ns t hat d o n ot r es ult i n h os pitalizati o n; 
or de vel o p me nt of dr u g d e pe n de n c y or dr u g a b use.  
A d diti o nall y, a n y s us pecte d tra ns missi o n via a Pfize r pr o d uct of a n i nfecti o us a ge nt, 
pat h o ge nic or n o n -p at h o ge nic, is c o nsi dere d seri o us.  T he e ve nt ma y b e s us pecte d fr o m 
cli nical s y m pt o ms or la b orat or y fi n di n gs i ndicati 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 mi ssi 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 onsi dere d u ne x p ec te d a n d h a n dle d as seri o us  e x pe dite d cases  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 1 9  of 3 7  
b y P V pers o n nel.  S uc h cases are als o c o nsi d ere 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 pitaliza ti 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) to a h os pital or 
eq ui vale nt healt hcare faci lit y or a n y pr olo n gati o n t o a n e xisti n g a d missi o n.   A d missi o n als o 
i ncl u des tra nsfer wit hi n t he h os pital t o a n ac ute/i nte nsi ve care u nit (e. g.,  fr o m t he ps yc hiatric 
wi n g t o a m e dical fl o or, me dical fl o or t o a c or o n ar y care u nit, n eur 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 pit alizati o n; 
h o we ver, a n e ve nt le a di n g t o a n e mer ge n c y r o o m vis it s h o ul d be assesse d f or me di cal 
i m p orta nce.   
H os pitalizati o n i n t he a bse nce of a me d ical A E is n ot i n itself a n A E a n d is n ot re p orta ble. 
F or e xa m ple, t he f oll o wi n g re p orts of h os pitalizati o n wit h o ut a me di cal A E are n ot t o b e 
re p orte d:  
•  S ocial a d missi o n (e. g., p atie nt has n o place t o slee p)  
•  A d mi nistrati ve a d missi o n (e . g., f or y earl y e xa m) 
•  O pti o nal a d missi o n n ot a ss 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 o s 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 tr eat me nt of a pre -e xisti n g c o n diti o n n ot ass oci ate d wit h t he d e v elo p me nt 
of a n e 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 
p ersiste nt pre-tr eat me nt l a b a b n or malit y) 
 
7. 3. 8. 3.  A d verse e v e n ts dat a c ollecti o n  
T h e i n vesti gat or c ollects d ata o n safet y e v e nts as s pecifie d i n Secti o n 7 i ncl u di n g all a d verse 
e ve nts t hat o cc ur d uri n g t he o bser vati o n peri o d re gar dless of ca us al relat i o ns hi p t o 
B E S P O N S A ® .  T he i nf or mati o n o n a d verse e v e nts s h o ul d i ncl u de t he s pecific c on diti o ns or 
e ve nts, d urati o n of t he e ve nt s (start d ate a n d st o p date), se verit y, acti o ns ta ke n,  seri o us ness  
(seri o us or n o n-s eri o us), o utc o me a n d ca usal rel ati o ns hi p t o B E S P O N S A ® . 
C hec k eit her ‘ y es’ or ‘ n o’ i n a d verse e ve nt occ urre nce s ectio n. If ‘ y es’, re cor d i n detail.  
•  A d verse e v e nts: Rec or d t he na me of a d verse e ve nt. If p ossi bl e, s pecif y dia g n osis, n ot 
i n di vid ual s y m pt o ms. Rec or d t he na me acc or di n g t o ‘N ati o n al C a ncer I nstit ute ( N CI) 
C o m m o n Ter mi n ol o gy Criteri a f or A dverse Eve nts ( C T C A E) Versi o n 4. 0 1 0’.  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 0  of 3 7  
•  Date of o nset : Rec or d t he da te of o ns et. Rec or d a p pr o xi mate date if a n act u al date is 
u n k n o w n.  
•  Se verit y : Se verit y e val uati o n of A E  m ust be d o ne acc or di n g t o g ra des of ‘N CI C T C A E  
Versi o n 4. 0 1 0’. If t he se verit y of a n A E  c ha n ge d, t he A E  m us t be e ntere d se paratel y. 
Rec or d st o p date of pre vi o us se ve rit y a n d o nset date of ne w se verity –  al o n g wit h 
c o m pleti o n of all  ot her ite ms.  
•  Acti o n : C hec k rele va nt acti o n of B E S P O N S A ®  d osa g e. Select o ne a m o n g ‘wit h dra w n 
(te m p oraril y or per m a ne ntl y, or dela ye d )’, ‘d ose re d uce d ’, ‘d os e i ncreas e d ’, ‘d oe s not 
ch a n ge d’, ‘u n k n o w n ’, or ‘n ot a p plica ble ’.  
•  S eri o us ness : C hec k eit her ‘yes ’ o r ‘n o ’. If ‘y es ’, rec or d t he a p pr o priate n u m ber f or t he 
cate gor y of seri o us ness.  
A seri o us a d verse e v e nt is a n y u nt o war d me dica l occ urre nce at a n y d ose t h at:  
① R es ults i n dea t h;  
② Is life-t hreate ni n g;  
③ R e q uires i n patie nt h os p italizati o n or pr ol o n gati o n of hos pitalizati o n;  
④ R es ults i n persiste nt or si g nifica nt disa bil it 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 ma l life f u ncti o ns);  
⑤ R es ults i n c o n ge nital a n omal y/ birt h de fect.  
⑥ Is i m p orta nt me dic al e ve nt (if it is deter mi ne d t hat t he e ve nt ma y je o par dize t he  
s u bject or  ma y re q uire i nter ve nti o n t o pre ve nt o n e of t he ot her o utc o mes liste d i n t he  
defi niti o n a b o ve ) 
 
C hec k t he f oll o wi n g at t h e e n d of t he st u d y  or  after t he res ol uti o n of A E .  
•  O utc o me : C hec k o n e a m o n g ' Rec o vere d’, ‘ Rec o vere d wit h se q uel ae’,  ‘ Rec o veri n g’, 
‘ N ot rec o v ere d’ or  ‘ U n k n o w n’ as a re pl y t o a q uesti o n;  ‘Is t he A E still prese nt?’. If t he 
stat us h as res ol ve d , rec or d the date of res ol uti o n. Re c ord a p pr o xi mat e  date if a n act ual 
date is u n k n o w n .  
•  Ca usalit y of a d v erse e v e nt t o  t he st u d y dr u g: T he ca us al rel ati o ns hi p of a d verse e ve nt 
t o t he st u d y dr u g m ust be all ocate d b y t he p h ysicia n acc or di n g t o t he f ollo wi n g criteria.  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 1  of 3 7  
① Certai n  
▪ It f oll o ws a reaso na ble ti me se q ue nce fr o m a d mi nistrati o n of t he  dr u g ( bef ore a n d 
after t he st u d y me dicati o n).  
▪ It c o ul d n ot be e x plai n e d b y ot her dr u gs, c he mical s u bsta nce or acc o m pa n yi n g 
diseases.  
▪ It has cli nicall y reas o na ble reacti o n o n ces sati o n of t he dr u g.  
▪ It h as ph ar mac ol o gical or p he n o me n ol o gical reacti o n t o re-a d mi nistrati o n of t he 
dr u g, w here necessar y.  
② Pr o ba ble/li kel y  
▪ It f oll o ws a reas o na ble ti me se q ue nce fr o m a d mi nistrati o n of t he dr u g ( bef ore a n d 
after t he st u d y me dicati o n).  
▪ It c o ul d n ot be e x plai n e d b y ot her dr u gs, c he mical s u bsta nce or acc o m pa n yi n g 
diseases.  
▪ It h as cli nicall y reas o n a ble reacti o n o n cessati o n of t he dr u g. ( N o i nf or mati o n o n re -
a d mi nistrati o n)  
③ P ossi ble  
▪ It f oll o ws a reas o na ble ti me se q ue nce fr o m a d mi nistra ti o n of t he dr u g.  
▪ It c o ul d als o be e x plai n e d b y ot her dr u gs, c he mical s u bsta nce or acc o m pa n yi n g 
diseases.  
▪ It lac ks i nf or mati o n or has u nclear i nf or mati o n o n disc o nti n uati o n of t he dr u g.  
④ U nli kel y  
▪ It is n ot li kel y t o ha ve a reas o na bl e ca us al relati o ns hip fr o m a d mi nistrati o n of t he 
dr u g. Rat her, it see ms t o be te m p orar y.  
▪ It c o ul d als o be reas o na bl y e x plai ne d b y ot her dr u gs, c he mical s u bsta nces or late nt 
diseases.  
* Ot her ca us alit y of a d verse e ve nt : If t h e a d verse e ve nt is n ot related t o t he st u d y dr u g,  
p h ysicia ns s h o ul d i n dicate t he m ost a p pr o priate ca use fr o m t he f oll o wi n gs a n d rec or d 
i n detail.  
( 1) Diseas e u n der t h e st u d y  
( 2) Ot her disease ( pl ease s pecif y)  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 2  of 3 7  
( 3) C o nc o mita nt treat me nt dr u g or n o n -dr u g ( pl ease s pecif y)  
( 4) Ot hers ( p lease s p ecif y)  
 
⑤ C o n diti o nal/ u nclassifie d  
▪ It n ee ds m or e data t o ma ke a n a p pr o priat e ass ess me nt or its a d diti o nal data are 
bei n g re vie we d.  
⑥ U naccessi ble/ u nclassifia ble  
▪ 
Lac k of s uffici e nt i nf or m ati o n or c o nflicti n g i nf or mati o n ha m pers acc urate ca usalit y 
assess me nt or s u p ple me ntati o n or c o nfir mati o n .  
 
7. 4.  St u d y Size  
1 2, 1 3 , an d  the a dj ust me nt a p plicati o n f or t he n u m ber of s u bjects , a n d 1 0 0  
s u bjects wi ll be c ollecte d d uri n g re-e xa mi nati o n peri o d. 
 
   
 
7. 5.  D at a S o urces  
I n m ost c ases, t he s o urce d oc u me nts are t h e hos pit al’s or t he p h ysicia n’s p atie nt  c hart.  
7. 6.  D at a m a n a ge me nt  
C R F data c ollecte d b y t he i n vesti gat or 
will be e ntere d i nt o t he cli nical data base.  
Verific ati o ns will be perf or me d aft er c o m paris o n of t he d o u ble data e ntr y.  All missi n g data 
or da ta t o be c hec ke d w ill be re p orte d o n a q u er y s heet f or f urt her verificati on at t he st u d y 
site. A n y data m o dificati o n will be rec or de d.   
 
7. 6. 1.  C ase re p ort f or ms  ( C R Fs)/ D at a c ollecti o n to ols  ( D C Ts)/ Electr o nic d at a rec o r d  
As use d i n t his pr ot oc ol, t he ter m C R F  sh o ul d be u n de rst o od  t o refer t o eit her a pa per f or m or 
a n electr o ni c data r ec or d or b ot h, 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 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)
C CI
C CI
C CI

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 3  of 3 7  
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 p atie nt.  T he c o m plete d 
ori gi nal C R Fs  are t he s ol e pr o pert y  of P fizer 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 ul at or y 
a ut h orities, wit h o ut writte n per missi o n fr o m Pfizer.  T he i n v esti gat or s hall e ns ure t hat t he 
C R F s are s ec ure l y sto re d at t he st u d y site i n e ncr y pte d electr o nic  a n d/ or p a p er f or m a n d will 
be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m  t o pre vent access b y u na ut h orize d t hir d 
parties.  
T he i n vesti gat or h as 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 al l cli nical, 
safet y, a n d la b orat or y d ata e ntere d o n t h e C RFs 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 n e o u s), e n d uri n g, a n d availa bl e w he n re q uir e d.  T he 
C R Fs m ust be si g ne d b y t he  i n vesti gat or or b y a n a ut h orize d staff me m b er t o attest t hat t he 
data c o ntai ne d o n t h e 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 ex p lai ne d (if necessar y) a n d s h o ul d n ot o bsc ure t he 
ori gi n al e ntr y.  
I n m ost cases t he s o urce d oc u me nts are t he h os pital or t he p h ysicia n's c hart.  I n t hese cases, 
data c ollecte d o n t h e C R Fs  m ust matc h t h ose c harts.  
I n s o me cases, t he C R F m a y als o ser v e as th e s o urce d o c u me nt.  I n t hes e cases, a d oc u me nt 
s h o ul d be a vaila ble at t he i n vesti gat or site a n d at Pfizer t hat clearl y i de ntifies t h ose data t hat 
will be rec or de d o n t he C R F , a n d f or w hic h t he C R F  will sta n d as t he s o urce d oc u me nt . 
 
7. 6. 2.  Rec o r d r ete nti o n      
T o  e na ble e val uati o ns a n d/ or i ns pecti o ns/a u dits fr o m re g u lat or y a ut h orities or Pfizer, t he 
i n vesti gat or a grees t o kee p rec or ds, i ncl u di n g t he i de ntit y of all partici pati n g patie nts 
(s ufficie nt i nf or m ati o n t o li n k rec or ds, e.g ., C R Fs a n d h os pital rec ords), all ori gi nal si g ne d 
i nf or me d c o ns e nt d oc u m e nts, c o pies of  all C R Fs, safet y re p orti n g f or ms, s o urce d oc u me nts, 
detaile d rec or ds of treat me nt dis p ositi o n, a n d a de q uate d oc u me nt ati o n of rele va nt 
c orres p o n d e nce (e .g ., letters, meeti n g mi n utes, a n d tele p h o ne ca ll re p orts).  T he rec or ds 
s h o ul d be ret ai ne d b y t h e i n vesti gat or acc or di n g t o l ocal re g ulati o ns or as s pecifi e d i n t he 
cli nical st u d y agree me nt  ( C S A), w hic he v er is l o n ger.  T h e i n vesti gat or m ust e ns ure t hat t he 
rec or ds c o nti n ue t o be st ored sec urel y f or s o  lo n g as t he y are retai n e d.  
If t he i n vesti gat or bec o mes una ble f or a n y reas o n t o c o nti n ue t o retai n st u d y rec or ds f or t he 
re q uire d peri o d (e. g., retire me nt, rel ocati o n), Pfi zer s h o ul d be pr os pecti v el y n otifie d.  T he 
st u d y rec or ds m ust be tra nsferre d to a d esi g n ee acce pt a ble t o Pfizer, s uc h as a n ot h er 
i n vesti gat or, a n ot her i nstit uti o n, or t o a n i n de pe n de nt t hir d part y arra n ge d b y Pfizer.  
St u d y  rec or ds m ust be ke pt f or a mi ni m u m of 1 5 years after c o m pleti o n or disc o nti n uati o n of 
t he st u d y, u nless if re q uir e d b y a p plica ble l o cal re g ulati o ns.  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 4  of 3 7  
T he i n ves ti gat or m ust o btai n Pfizer's writte n per missi o n bef ore dis p osi n g of a n y rec or ds, 
e ve n if rete nti o n re q uir e me nts ha ve bee n m et.  
 
7. 7.  D at a a n al ysi s 
A nal ysis will be perf or m e d f or safet y gr o u p a n d effecti ve n ess gr o u p.  
•  S afet y gr o u p: S u bjects w h o ha ve bee n a d mi nis tere d B E S P O N S A ®  at least o nce a n d 
e val uate d wit h safet y -rel ate d e n d p oi nts at least o n ce.  
•  Effecti ve n ess gr o u p: S u bjects w h o ha ve bee n e val uate d bas e d u p o n effecti ve n ess 
e n d p oi nts as desc ri be d i n t his pr ot oc ol.  
De taile d met h o d ol o g y f or s u m mar y a n d statistical a nal yses of data c ollecte d i n t his st u d y will 
be d oc u me nt e d i n a Statistical A nal ysis Pla n ( S A P), w hic h will be date d, file d a n d 
mai ntai ne d b y t he s p o ns or. T he S A P m a y m o dif y t he pla ns o utli ne d i n t he pr ot oc ol; a n y 
maj or m o dificati o ns of pri mar y e n d p oi nt d efi 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.  
 
7. 7. 1.  S afet y a n al ysis  
•  Safet y para meter  
◼ C o u nt a n d fre q ue n c y of occ urre nce of a d v erse e ve nt , seri o us a d v erse e ve nt, 
a d verse dr u g re acti o n or u n e x pecte d a d verse e v e nt b y cate g or y.   
◼ C o u nt  a n d fre q ue n c y of occ urre nce of a d v erse e v e nts b y s u bject baseli ne fact or 
a n d b y treat me nt f act or t o deter mi ne fact ors affecti n g t he safet y.  
•  S u b -a nal ysis ma y be perf or m e d utilizi n g fact ors w hic h are c o nsi dere d t o  affect safet y. 
If re q uir e d, c hi-s q u are test ( X2-test) will be use d f or s u b gr o u p a nal ysis.  
 
7. 7. 2.  Effecti v e ness a n al ysis  
•  Effecti ve n ess  para meter  
◼ Res p o nse after eac h c y cle : C R, C R i, Refract or y disease, Pr o gressi ve disease, 
Rela pse d dis ease  
◼ F inal eff ecti ve n ess : C R, C R i, Refract or y disease, Pr o gressi ve disease, Rel a pse d 
disease   
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 5  of 3 7  
➢ Effecti ve n ess para meters will be des cri pti vel y s u m marize d. If necessar y, Χ 2-test, 
paire d t -test, a n al ysis b y re peat e d meas ure me nt, a n d ot her statistical met h o ds will be 
use d.  
 
7. 7. 3.  I nteri m A n al ysis  
As re q uir e d b y M F D S  re g ulati o ns, t he peri o dic rep ort s h o ul d b e s u b mitte d t o M F D S  e ver y 6 
m o nt hs f or t he first t w o years a n d t he n a n n u al re p ort s h o ul d be s u b mitte d t o M F D S  f or t he 
t hir d, f o urt h a n d fift h y ear. T h e fi nal re p ort s h o ul d be s u b mitte d i n t he si xt h year. I nteri m 
a nal ysis will be perf or m e d i n ti me f or t he r e p ort s u b missi o n.  
 
7. 8.  Q u alit y co ntr ol  
Q ualit y ass ura nce a u dits will be perf or m e d at st u d y ce nters b y t h e Pfizer’s o w n i n de pe n de nt 
q ualit y ass ura nce gr o u p or b y cli nical res earc h or ga nizati o n .  T hese a u dits will be  c o n d ucte d 
acc or di n g t o Pfizer’s pr oce d ures a n d t he g ui deli nes f or 
G o o d P har mac oe pi de mi ol o g y 
Practices ( G P P) (s ee Secti o n  8. 4 ). 
 
7. 9.  Li mit ati o ns of t he rese arc h met h o ds  
T his is a n o n-i nter ve nti o nal P M S st u d y c o n d ucte d i n t he Re p u blic of K orea t o satisf y t he 
re q uire me nts of M F D S . T he pr ot oc ol is d eter mi ne d b y re g ul ati o n of M F D S a n d n ot t he 
s pecific dise ase a n d dr u g c haract eristics.  
T he o bser vati o nal, n o n -c o ntr olle d, a n d 
n o n -ra n d o mize d d esi g n of t his st u d y has i ntri nsic li mitati o ns. 
 
8.  P R O T E C TI O N O F H U M A N S U B J E C T S  
8. 1.  P atie nt inf 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 directl y i de ntifia ble data i n a n y 
re ports, p u blicati o ns, or ot her discl os ures, e x ce pt w here re q uire d b y a p plica ble la ws.  
 
T he pers o nal dat a will be st ore d at t he st u d y site i n  e ncr y pte d electr o nic  a n d/ or pa per  f or m 
a n d will be p ass w or d pr otec te d or sec ure d i n a l oc ke d r o o m t o e ns ure t h at onl y a ut h orize d 
st u d y staffs 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 me as ures t o e ns ure t hat t he p ers o nal data ca n b e rec o v ere d i n t he e ve nt of 
disaster.  I n t he e v e 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 otifi cati o ns as re q uire d b y la w.  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 6  of 3 7  
T o pr otect t he ri g hts a n d free d o ms of n at ural pers o ns wit h re gar d t o t he pr ocessi n g of 
pers o nal d a ta, w h e 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 pecific, n u merical 
c o de, base d o n a n u m beri n g s yste m defi ne d b y Pfizer .  All ot her i de ntifia ble data tra n sferre 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, pati e nt-s pecific c o d e.  
T he i n vesti gat or site will mai ntai n a c o nfi de ntial list of patie nts w h o partici pate d i n t he st u d y, 
li n ki n g eac h patie nt’s n u merical c o de t o his or h er 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 d ata 
c o nsiste nt wit h t he cli nical st u d y agree m e nt  a n d a p plica ble pri vac y l a ws.  
 
8. 2.  P atie nt c o nse nt  
T he i nf or me d c o ns e nt  d oc u me nts a n d a n y patie nt recr uit me nt 
mat erials 
m ust be i n 
c o m plia nce wit h l ocal re g ulat or y re q uire me nts a n d le gal re q uire me nts, i ncl u di n g a p plica ble 
pri vac y la ws.  
T he i nf or me d c o nse nt  d oc u me nts use d d uri n g t he i nf or me d c o nse nt pr ocess a n d a n y patie nt 
recr uitme nt mat erials m ust be re vie we d a n d a p pr o ve d b y Pfizer, a p pr o ve d b y t he i nstit uti o nal 
re vie w b o ar d (I R B)/i n de pe n de nt et hics c o m mittee (IE C ) bef ore use, a n d a vaila bl e f or 
i ns pecti o n. 
T he i n vesti gat or m ust e ns ure t hat eac h st u d y patie nt  is f ull y i nf or me d a b out t he nat ure a n d 
o bjecti ves of t he st u d y, t he s hari n g of data relati n g t o t he st u d y a n d p ossi ble ris ks ass ociate d 
wit h partici pati o n, i ncl u di n g t he ris ks ass ociat e d wit h t he pr ocessi n g of t h e patie nt’s p ers o nal 
data.  T he i n v esti gat or f urt her m ust e ns ure t hat eac h st u d y patie nt is f ull y i nf or me d a b o ut his 
or her ri g ht t o access a n d c orrect his or h er p ers o nal data a n d t o wit h dra w c o nse nt f or t he 
pr ocessi n g of his or her pers o nal data.  
T he i n vesti gat or m ust e ns ure t hat eac h st u d y patie nt , or his or her le ga ll y acce pta ble 
re pres e ntati ve, or pare nt(s) or le gal g uar dia n if a mi n or, is f ull y i nf or me d a b o ut t he nat ure 
a n d o bjecti ves of t he st u d y, t he s hari n g of dat a relati n g t o t he st u d y a n d p ossi ble ris ks 
ass ociate d wit h partici p ati o n, i ncl u di n g t he ris ks ass oci ate d wit h t he pr ocessi n g of t he 
patie nt’s pers o nal d ata.  T he i n vesti gat or f urt h er m ust 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 nt ati ve, or p are nt(s) o r le gal g uar dia n if a mi n or, is f ull y 
i nf or me d a b o ut his or her ri g ht t o access a n d c orrect his or her pers o nal data a n d t o wit h dra w 
c o nse nt f or t he pr ocessi n g of his or her pers o nal d ata.  
W he ne v er c o ns e nt is o btai ne d fr o m a p atie nt’ s le gall y acce pt a ble re prese ntati ve/ pare nt(s) or 
le gal g uar dia n, the patie nt’s asse nt (affir mati ve a gree m e nt) m ust s u bse q ue ntl y be o btai ne d 
w he n t he patie nt has t he ca pacit y t o pr o vi de ass e nt, as deter mi ne d b y t h e I R B/ IE C.  If t he 
i n vesti gat or deter mi nes t hat a p atie nt’s decisi o nal ca p acit y is s o li mite d t h at he or s he ca n n ot 
reas o na bl y be c o ns ulte d, t he n, as per mitte d b y t he I R B/IE C a n d c o nsiste nt wit h l ocal 
re g ulat or y a n d le gal re q uire me nts, t he p atie nt’s asse nt 
ma y be 
wai ve d 
wit h s o urce 
d oc u me ntati o n of t he reas o n asse nt was n ot o btai ne d.  If t he st u d y p atie nt d oes n ot pr o vi de 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 7  of 3 7  
his or her o w n c o nse n t, t he s o urce d o c u me nts m ust rec or d w h y t he patie nt di d n ot pr o vi de 
c o nse nt (e. g., mi n or, decisi o nall y i m paire d a d ult), h o w t he i n vesti gat or deter mi ne d t hat t he 
pers o n si g ni n g t he c o ns e nt was t h e patie nt’s le gall y acce pta ble re prese ntati ve, t he c o ns e nt 
si gner’s relati o ns hi p t o t he st u d y patie nt (e. g., pare nt, s p o use), a n d t hat t he patie nt’s asse nt 
was o btai ne d or w ai ve d.  If asse nt is o btai ne d ver ball y, it m ust be d oc u me nte d i n t he s o urce 
d oc u me nts.  
T he i n vesti gat or, or a p ers o n desi g nate d b y t he i n vesti gat or, will o btai n writte n i nf or me d 
c o nse nt fr o m eac h p atie nt or t he patie nt’s le gall y acce pta bl e re prese ntati ve, pare nt(s), or le gal 
g uar dia n a n d t he patie nt’s asse nt, w he n a p plica ble,  bef ore a n y st u d y -s pecific acti vit y is 
perf or me d  u nless a wai ver of i nf or m e d c o nse nt has bee n gra nte d b y a n I R B/I E C .  T he  
i n vesti gat or will retai n t he ori gi nal of eac h patie nt's si g ne d c o nse nt d oc u me nt.  
 
8. 3.  P atie nt wit h dr a w al  
Patie nts  ma y wit h dra w fr o m t he st u d y at a n y ti me at t heir o w n re q uest, or t he y ma y b e 
wit h dra w n at a n y ti me  at t he discreti o n of t he i n vesti gat or or s p o ns or f or safet y, be ha vi or al, 
or a d mi nistrati ve reas o ns. I n a n y cir c u msta nce, e ver y eff ort s h o ul d b e ma de t o d o c u me nt 
s u bject o utc o me, if p ossi ble. T he i n vesti gat or s h o ul d i n q uire a b o ut t he reas o n f or wit h dra wal 
a n d f oll o w-u p wit h t he s u bject re gar di n g a n y u nres ol ve d a d verse e v e nts.   
If t he patie nt  wit h dra ws fr o m t he st u d y, a n d als o wit h dra ws c o nse nt f or discl os ure of f ut ure 
i nf or mati o n, n o f urt her e val uati o ns s h o ul d be perf or me d, a n d n o a d diti o nal data s h o ul d be 
c ollecte d. T he s p o ns or ma y retai n a n d c o nti n ue t o use a n y data c ollecte d bef ore s u c h 
wit h dra wal of c o nse nt.  
 
8. 4.  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)  
T h e st u d y pr ot oc ol will be s u b mitte d t o M F D S pri or t o t he st u d y .  T he et hical c o nsi derati o n 
o n t his st u d y will be e val uate d b y I R B/I E C i n eac h cli nical site pri or t o t he st u d y if t he site 
has a n a p pr o val pr ocess f or t his P M S st u d y acc or di n g t o t h e l ocal sta n dar d o perati o n 
pr oce d ure of t he site.  
It is t he res p o nsi bilit y of t he i n vesti gat or t o ha ve pr os pecti ve a p pr o val of t he st u d y pr ot oc ol, 
pr ot oc ol a me n d me nts, a n d ot her rele va nt d o c u m e nts, if a p plica ble, fr o m t he I R B/I E C.  All 
c orres p o n d e nce wit h t he I R B/I E C s h o ul d be retai ne d i n t he I n vesti gat or File.  C o pies of 
I R B/I E C a p pr o v als sh o ul d be f or war de d t o Pfizer  or its desi g nee .  
 
8. 5.  Et hic al C o n d uct of t he St u d y  
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 uir e me nts, as well as 
wit h scie ntific p ur p ose, val ue a n d ri g or a n d f oll o w ge nerall y acce pte d researc h practi ces 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 8  of 3 7  
descri be d 
i n 
G ui deli nes 
f or 
G P P 
iss ue d 
b y 
t he 
I nter n ati o nal 
S ociet y 
f or 
P har mac oe pi de mi ol o g y (I S P E), G o o d E pi de mi ol o gical Practice ( G E P) g ui deli nes iss ue d b y 
t he I nter nati o nal 
E pi de mi ol o gical 
Ass ociati o n (I E A), 
P har mace utical 
Researc h a n d 
Ma n ufact ur ers  Ass ociati o n ( P h R M A) g ui deli nes , a n d K orea P M S re g ulati o ns a n d/ or 
g ui deli nes .  
 
9.  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  
9. 1.  Re q uire me nts  
T he ta ble bel o w s u m marizes t he re q uir e me nts f or rec or di n g safet y e ve nts o n t he  case re p ort 
f or m a n d for re p orti n g safet y e ve nts o n t he n o n -inter ve nti o nal st u d y ( NI S) ad v erse eve nt 
m o nit ori n g ( A E M) R e p ort F or m  t o Pfizer Safet y.  T hes e 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 v e nts (S A Es); ( 2) n o n -seri o us A Es (as a p plica ble); 
a n d ( 3) sce n ari 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, m e dicati o n err or, o ver d ose, mis use, e xtra v asati o n, a n d occ u p ati o nal 
e x p os ure.  T h ese e v e nts are defi ne d i n t he secti o n “ Defi niti o ns of safety e v e 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 Pfi zer 
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 n e 
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 ur e d uri n g 
breast fee di n g, me dicati o n 
err or, o ver d ose, mis use, 
e xtra vas ati o n; lac k of efficac y; 
a n d occ u p ati o nal e x p os ure  
All (re gar dl ess of 
w het her ass o ciate d wit h 
a n A E), e x ce pt 
occ u p ati o n al e x p os ure  
All (re gar dl ess of w het h er 
ass ociate d wit h a n A E)  
 
F or eac h A E, t h e i n vesti gat or m ust p urs ue a n d o bt ai n i nf or mati o n a de q u ate b ot h t o deter mi ne 
t he o utc o me of t he a d verse e ve nt a n d t o assess w het her it meets t he criteria f or classificati o n 
as a S A E (see secti o n " Seri o us A d verse E ve nts”  b el 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 h e e v e nt b y t he i n vesti gat or  re g ar dless of w het her t he e ve nt is deter mi ne d 
b y t he i n vesti g at or t o be rel ate d t o a dr u g u n der st u d y . I n partic ul ar, if t he S A E is fatal or 
life-t hreat e ni n g, n otificati o n t o Pfizer m ust be m a de i m me diatel y, irres p ecti ve of t he e xte nt of 
a vaila ble e v e 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) 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 2 9  of 3 7  
i nf or mati o n o n pre vi o usl y f or war de 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 bec o me i m me diatel y a ware of t he occ urre n ce of a safet y e v e nt, t he 
i n vesti gat or m ust re p ort t he e v e 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 n ess 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 n eral, t his will i ncl u de a descri pti o n of t he a d verse e ve nt 
i n s ufficie nt detail t o all o w f or a c o m plete m e dical assess me nt of t he case a n d i n de pe n d e 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 h e 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 nt ati ve.   
 
9. 2.  Re p orti n g peri o d  
F or eac h patie nt, t he safet y e ve nt r e p orti n g peri o d be gi ns at t he t i me of t he patie nt’s first d ose 
of B E S P O N S A ® , or t he ti me of t h e patie nt’s data pri vac y stat e me nt  if s/ he is alrea d y e x p ose d 
t o B E S P O N S A ® , a n d lasts t hr o u g h t he e n d of t he o bser vati o n peri o d of t he st u d y, w hic h m ust 
i ncl u de at least 2 8 cal e n dar da ys f oll o w i n g t he l ast a d mi nistrati o n of a dr u g u n der st u d y; a 
re p ort m ust be s u b mitte d t o Pfizer Safet y ( or its desi g nate d re prese ntati ve) f or a n y of t he 
t y pes of safet y e ve nts liste d i n t he ta ble a b o ve occ urri n g d uri n g t his peri o d.  If a patie nt was 
a d mi nistere d a  dr u g u n der st u d y o n t he last da y of t he o bser vati o n peri o d, t he n t he re p orti n g 
peri o d s h o ul d be e xte n d e d f or 2 8 cal e n dar da ys f oll o wi n g t he e n d of o bser vati o n.    
M ost ofte n, t he date of d ata pri vac y stat e me nt  is t he sa me as t he dat e of e nr oll me nt. I n s o me 
sit uati o ns, t here ma y be a la g bet wee n t he dates of data pri vac y state me nt  a n d e nr oll me nt.  I n 
t hese i nsta nces, if a patie nt pr o vi des data pri v ac y state men t b ut is ne ver e nr olle d i n t he st u d y 
(e. g., patie nt c ha n g es his/ her mi n d a b o ut partici pati o n), t he re p orti n g peri o d e n ds o n t he date 
of t he decisi o n t o n ot e nr oll t he patie nt.  
If t he i n vesti gat or bec o mes a ware of a S A E o cc urri n g at a n y 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 b e relate d t o B E S P O N S A ® , t he S A E als o m ust be 
re p orte d t o Pfizer Safet y 
 
9. 3.  C a us alit y assess m e 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 rel ati 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 d verse e ve nt.  F or A Es  wit h a ca usal relati o ns hi p t o  B E S P O N S A ® , f oll o w-u p b y t he 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3 0  of 3 7  
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 st a bilize at a le vel 
acce pta ble t o t he i n vesti g at 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 n t is t he deter mi nati o n of w het h er t here e xists a 
reas o na bl e p ossi bilit y t hat B E S P O N S A ®  ca us e d or c o ntri b ute d t o a n a d verse e v e nt. 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 n e 
w het her B E S P O N S A ®  ca use d t he e ve nt, t he s afet y e ve nt m ust be re p ort e d wit hi n 2 4 h o urs.   
If t he i n vesti gat or ca n n ot deter mi ne t he eti ol o g y of t he e ve nt b ut s/ he deter mi nes t hat  
B E S P O N S A ®  di d n ot ca use t he e ve nt, t his s h o ul d be clearl y d oc u me nte d o n t he C R F a n d t he 
NI S A E M  Re p ort F or m .  
 
9. 4.  Defi niti o ns of S afet y E ve nts  
9. 4. 1.  A d verse e v e nts  
Refer t o t he ‘ 7. 3. 8. 1.  Defi niti o n of a d verse e v e nts’ cla use.  
9. 4. 2.  Seri o us a d verse e ve nts  
Refer t o t he ‘ 7. 3. 8. 2. Defi niti o n  of seri o us  a d verse e ve nts ( S A Es)’ cla use.  
 
9. 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 n c y, e x p os ure d uri n g breastf ee di n g, me dicati o n 
err or, o v er d ose, mis use, e xtra vas ati o n , lac k of efficac y, a n d o cc u p ati o nal e x p os ure are 
descri be d b el o w.  
E x p os ure d uri n g pre g na n c 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 h a vi n g bee n  
e x p ose d t o (e.g ., e n vir o n me ntal) B E S P O N S A ® , or t he fe male bec o mes, or is f o u n d t o 
be, pre g n a nt after disc o nti n ui n g a n d/or bei n g e x p ose d t o B E S P O N S A ®  ( mater nal 
e x p os ure). 
A n e xa m ple of e n vir o n me ntal e x p os ure w o ul d be a case i n v ol vi n g direct c o ntact wit h 
a Pfizer pr o d uct i n a pre g na nt w o ma n (e. g., a n urse re p orts t hat s he is pre g na nt a n d 
has bee n e x p os e d t o c he m ot hera pe utic pr o d u cts).  
2.  A  male  h as 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 
B E S P O N S A ®  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 n c y ( pat er nal e x p os ure) . 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3 1  of 3 7  
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, d ata  o n t he e x p os ure t o 
B E S P O N S A ®  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 vers e e v e nts. 
As a ge neral r ule, pr os p ecti ve a n d retr os pecti ve e x p os ure d uri n g  pre g na n c 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 n ce 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 b e 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 des cri be d i n ab o ve ), f or w hic h dat a o n t he e x p os ure are n ot re p orta bl e u nless 
ass ociate d wit h s eri o us or n o n-seri o us a d v erse e ve nts. 
If a st u d y partici pa nt  or st u d y partici pa nt ’s part ner b ec o mes, or is f o u n d t o be, pre g n a nt 
d uri n g t h e st u d y partici pa nt ’s treat me nt 
wit h B E S P O N S A ® , 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 d verse e ve nt has occ urre 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 .  
I n a d diti o n, t he i nf or mati o n re gar di n g e n vir o nme ntal e x p os ure t o B E S P O N S A ®  i n a pre g na nt 
w o ma n (e .g ., a s u bject 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 b e d o ne irres pecti ve of w het her a n A E has occ urre d.   
Inf 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 ve r 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 or mati o n o n E D P o utc o me f or all  E D P  re p orts wit h pre g na nc y  
o utc o me  u n k n o w n .  A  pre g na nc y is f oll o we d u ntil c o m 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 h e case of a li ve birt h, t he stru c t ural i nte grit y of 
t he ne o nate ca n be ass esse d at t he ti me of birt h.  I n t he e v e nt of a ter mi nati o n, t he reas o n(s) 
f or ter mi nati o n s h o uld be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural i nte grit y of t he 
ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless pre -pr oce d ure test 
fi n di n gs are c o n cl 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, n e o natal deat h, or c o n g e nital a n o mal y [i n a 
li ve b or n, a ter mi nate d fet us, a n i ntra uteri ne fetal de mise, or a ne o natal deat h]), t he 
pr oce d ures f or re p orti n g S A Es  s h o ul d be f oll o we d. 
A d diti o nal i nf or mati o n a b o ut pre g na nc y o utc o m es 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 u l 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 nf a nt deat h as rel ate 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  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3 2  of 3 7  
A d diti o nal i nf o r mati o n re gar di n g t he e x p os ure d uri n g pre g na nc y ma y be re q ueste d.  F urt her 
f oll o w-u p of birt h o utc o mes will be ha n dle d  o n a case -b y -case basis (e .g ., f oll o w-u p o n 
preter m i nfa nts t o i de ntif y de vel o p me ntal dela ys).   
I n t he case of pater n al e x p os ure, t he stu d y partici pa nt will be pr o vi de d  wit h t he Pre g na nt 
Part ner Rele ase of I nf or mati o n F or m t o d eli ver t o his part ner.  It m u st be d oc u me nt e d t hat t h e 
st u d y partici pa nt was gi v e 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 b reastfee di n g re p ort is n ot create d w he n a Pfizer dr u g 
s pecificall y a p pr o ve d f or use i n breastf ee 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 o ciate d wit h s uc h a 
dr u g’s a d mi nistrati o n,  t he A E is re p ort e 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 m e dici nal pr o d u ct t h at ma y ca use or lea d t o i na p pr o priate me dicati o n u se or patie nt har m 
w hile i n t he c o ntr ol of t he healt h care pr ofessi o n al, patie nt, or c o ns u mer.  S uc h e ve nts ma y 
be rel ate d t o pr ofessi o n al practice, healt h care pr o d ucts, pr oce d ures, a n d s yste ms i ncl u di n g: 
prescri bi n g; 
or der c o m m u 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 or s i ncl u d e: 
•  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 n a d verte nt/err o ne o us 
a d mi nistrati o n, w hi c 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 d e 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 d icati o n err ors t o Pfizer, irres pecti ve of t he 
prese nce of a n ass ociate d A E/ S A E : 
•  Me dicati o n err ors i n v ol vi n g patie nt e x p os ure t o t he pr o d uc t, 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 h at d o n ot i n v ol ve a patie nt direct l y (e. g., p ote ntial me dicati o n 
err ors or near misses ).  W he n a m e 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 owi 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 ; 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3 3  of 3 7  
•  T he e ve nt me d icati o n err or. 
O ver d ose, Mis use, E xtr a vasati o n  
Re p orts of o ver d os e, mis use, a n d e xtra vas ati o n ass ociate d wit h t he use of a Pfizer pr o d u ct are 
re p orte d t o Pfizer b y t he i n vesti gat or, irres pecti ve of t he prese n ce of a n ass ociate d A E/ S A E .  
Lac k of Efficac y  
La c k of effi cac y is d efi ne d as t he fail ure of e x pecte d p har mac ol o gic acti o n or t hera pe utic 
be nefit.  
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 oci ate d A E/ S A E or t he i n dica tio n f or use of t he Pfizer 
pr o d uct.  
Occ u pati o nal E x p os ur e  
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 the i n vesti gat or , 
irres pecti ve of t he prese n ce of a n ass ociate d A E/ S A E .  
Base d o n t he “ Safet y I nf or mati o n Ma na ge me nt R e g u lati o ns f or Dr u gs, Etc.”, t he staff i n 
c har ge of safet y i nf or mati o n at Pfizer K orea re p orts t o t he Direct or of K orea I nstit ute of Dr u g 
S afet y a n d Ris k Ma na ge me nt via we bsite, tele p h o ne, fa x, mail or i n t he f or m of electr o nic 
d oc u me nt usi n g A p pe n di x F or m n o . 1 i n t he Safet y I nf or mati o n Ma na g e me nt Re g ulati o ns f or 
Dr u gs, Etc. ( M F D S N otificati o n) wit hi n 1 5 da ys of a ware ness or bei n g n otifie d o f t he seri o us 
a d verse e ve nt/a d v erse dr u g reacti o n i n acc or da nce wit h Article 5 Para gra p h 4 of t he Re -
e xa mi nati o n G ui de line of N e w D r u gs, Et c ( M F D S N otificati o n n o. 2 0 1 5-7 9). T heref ore, i n 
case of a seri o us a d vers e e ve nt/a d verse dr u g reacti o n, t he i n vesti ga t or i m me diatel y n otifies 
t he staff i n c har ge of s afet y i nf or mati o n at Pfizer K orea. T h e i n vesti gat or c o m pletes t he 
‘ N on -I nter ve nti o nal St u d y A d verse E v e nt Re p ort F or m’ a n d m ust f a x it wit hi n 2 4 h o urs of 
a ware ness  of t he a p plica ble seri o us a d verse e v e nt/a d v erse dr u g reacti o n.  
 
9. 5.  Si n gle refere nce s afet y d oc u me nt  
T he latest versi o n of t he L P D  of B E S P O N S A ®  will ser ve as t he S R S D d uri n g t he c o urse of 
t he st u d y, w hic h will be use d b y Pfizer t o assess a n y safet y e ve nts re p ort e d t o Pfizer Safet y 
b y t he i n vesti gat or d uri n g t he c o urse of t his st u d y.  
T he S R S D s h o ul d be use d b y t he i n vesti gat or f or prescri bi n g p ur p os es a n d g ui da nce.  
 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3 4  of 3 7  
1 0.  P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S  
F or t he first 2 years, 6 -m o nt h re p orts will be s u b mitte d t o M F D S (i.e., re p orts 1 -1 , 1-2, 2 -1, 
a n d 2 -2 ).  T hereaft er, data c ollecte d i n t he 3r d, 4t h, a n d 5t h year will be re p orte d t o M F D S 
a n n uall y.  Fi na l st u d y re p ort (i.e., re-e xa mi nati o n re p ort) will be s u b mitte d t o M F D S i n t he 
6 t h year t o  i ncl u de all data c ollecte d d uri n g t he w h ole stu d y peri o d .  
C O M M U NI C A TI O N O F I S S U E S  
I n t he e ve nt of a n y pr o hi biti o n or restricti o n i m p ose d (e. g., cli nical h ol d) b y an a p plica ble 
C o m pete nt A ut h orit y i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n w hic h mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of a Pfizer pr o d uct, 
Pfizer s h o ul d be i nf or me d i m me diatel y.   
I n a d diti o n, t he i nv esti gat or will i nf or m Pfizer i m me diatel y of a n y ur ge nt safet y m eas ures 
ta ke n b y t he i n vesti gat or t o pr otect t h e st u d y pati e nts a gai nst a n y i m me diate hazar d, a n d of 
a n y seri o us breac h es of t his NI  st u d y pr ot oc ol t hat t he i n vesti gat or bec o mes a ware of.   
 
1 1.  P U B LI C A TI O N O F S T U D Y R E S U L T S  
Pfizer f ulfils its c o m mit me nt t o p u blicl y discl ose st u d y res ults t hr o u g h p osti n g t he res ults of 
t his st u d y o n w w w.cli nicaltrials. g o v. Pfizer p osts t he res ults of all st u dies t hat is has 
re gistere d o n Cli nical Tri als. g o v re gar dl ess of t he reas o n f or re gistrati o n.  
T he res ults are p oste d i n a ta b ular f or mat calle d B asic Res ults.  
•  Basic Res ults are d ue wit hi n o ne a n ni v ersar y year of t he P C D a n d/ or L S L V.  
•  W he n P C D a n d L S L V are n ot t he sa me date, Basic Res ults are p oste d o ne 
a n ni versar y ye ar fr o m t h e P C D a n d t he rec or d is u p date d o ne a n ni versar y year fr o m 
t he L S L V. T he P C D ca n n ot occ ur after t he L S L V. 
 
 
 
 
 
 
 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3 5  of 3 7  
 
1 2.  R E F E R E N C E S  
1.  O’ Brie n S, T h o mas D, Ra va n di F, et al. O utc o me of a d ults wit h ac ute ly m p h ocytic le uke mi a after 
sec o n d s alv a ge t her a py. C a ncer  2 0 0 8; 1 1 3( 1 1): 3 1 8 6 -9 1.  
2. T h o mas D A, Ka ntarjia n H, S mit h T L, K oller C, C ortes J, O' Brie n S, Giles FJ, Gaje ws ki J,  Pie rce S, 
Keati n g MJ. Pri m ary Refr act ory a n d Rel a pse d A d ult Ac ute Ly m p h o bl astic  Le uke mi a: C h ar acteristics, 
Tre at me nt Res ults, a n d Pr o g n o sis wit h S alv a ge T her a py. C a ncer 1 9 9 9; 8 6( 7): 1 2 1 6 -3 0.  
3. Nati o nal Ca ncer I nstit ute. S E E R Ca ncer Statistics Re vie w, 1 9 7 5 -2 0 1 1  
htt p://seer. ca ncer. g o v/arc hi ve/csr/ 1 9 7 5 _ 2 0 1 1/  
4. Sie gel R, Ma J, Z o u Z, Je mal A. C a ncer St atistics, 2 0 1 4. C A C a ncer J Cli n  2 0 1 4; 6 4 : 9-2 9.  
5. B o ue D R a n d Le Bie n T W. Ex pressi o n a n d Str uct ure of C D 2 2 i n Ac ute Le uke mi a. Bl o o d  1 9 8 8; 
7 1( 5): 1 4 8 0 -6.  
6. de Vries J F , Z waa n C M, De Bie M, V oer ma n J S, de n B oer M L, va n D o n ge n JJ, va n der  Vel de n 
V H. T he N ovel C alic he a mici n -C o nj u g ate d C D 2 2 A nti b o dy I n o t uz u m a b Oz o g a mici n( C M C-5 4 4) 
Effectively Kills Pri m ary Pe di atric Ac ute Ly m p h o bl astic Le uke mi a Cells.  Le uke mi a . 2 0 1 2; 2 6: 2 5 5-6 4.  
7. Has o W,  Lee D W, S ha h N N, Stetler -Ste ve ns o n M, Y ua n C M, Pasta n I H, Di mitr o v D S,  M or ga n 
R A, Fitz Geral d DJ, Barrett D M, 
Wa y ne A S,  Mac kall C L a n d Ore ntas RJ. 
A nti -C D 2 2 – C hi meric 
A nti ge n Rece pt ors T ar geti n g B -cell Prec urs or Ac ute Ly m p h o bl astic  Le uke mi a. B l o o d. 2 0 1 3; 12 1 
( 7): 1 1 6 5-1 1 7 4.  
8 . Ka ntarjia n H M, De A n gel o DJ, Stelljes M, Lie dt ke M, St oc k W,  G ö k b u get N, O' Brie n S M, Ja b b o ur 
E, Wa n g  T, Lia n g W hite J, Slei g ht B, Va n de n dries E, A d va ni A S. I n ot uz u ma b oz o ga mici n vers us 
sta n dar d of care i n rela pse d or refrac t or y ac ute l ym p h o blastic le u ke mia: Fi nal re p ort a n d l o n g -ter m 
s ur vi val f oll o w-u p fr o m t he ra n d o mize d, p hase 3 I N O -V A T E st u d y. 
Ca nce r. 2 0 1 9 J ul 
1 5; 1 2 5( 1 4): 2 4 7 4 -2 4 8 7.  
9. Nati o nal C o m pre he nsi ve Ca ncer Net w or k. N C C N Cli nic al Pr actice G ui deli nes i n O nc ol o gy. Ac ute 
Ly m p h o b lasti c Le uke mi a Versi o n 2. 2 0 1 6 . htt p:// N C C N. or g  
1 0. Nati o nal Ca ncer I nstit ute. C o m m o n Ter mi n ol o gy Criteri a f or A dverse Ev e nts Versi o n 4. 0 . 2 0 0 9.  
1 1. K o rea n Statistical I nf or mati o n Ser vice.  
htt p:// k osis. kr/statistics List/statistics Li stI n de x. d o? me n uI d = M _ 0 1 _ 0 1 & v wc d = M T _ Z TI T L E & par m Ta b
I d = M _ 0 1 _ 0 1 &statI d = 1 9 9 7 0 1 8 &t he maI d = D # Select Stats B o x Di v 
1 2 . Z ha o Y et al . J He m at ol O nc ol. 2 0 1 3 ; 6: 4 0 
1 3. Ori ol A et al.  H ae m at ol o gic a. 2 0 1 0; 9 5( 4): 5 8 9 -5 9 6  
 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3 6  of 3 7  
A P P E N DI C E S  
A P P E N DI X 1. R E S P O N S E C RI T E RI A   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)

B E S P O N S A ®  (I n ot uz u ma b Oz o ga m yci n) 
< B 1 9 3 1 0 2 7 >  N O N -I N T E RV E N TI O N A L S T U D Y P R O T O C O L  
A me n d me nt 4 , 0 7  N o v  2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 1 6. 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy 0 1 -
A u g -2 0 2 3   
Pa ge 3 7  of 3 7  
A P P E N DI X 1. R E S P O N S E C RI T E RI A  
Res p o nse C riteria is defi ne d  acc or di n g t o ‘N C C N G ui deli ne Versi o n 2. 2 0 1 6 Ac ute 
Ly m p h o bl astic Le uke mi a 9’. 
 
T he bel o w o utc o me d efi niti o ns will be use d f or re p orti n g of  res p o nse assess me nts . 
 
Res p o nse Criteria f or Bl o o d a n d B o ne Marr o w : 
•  C o m plete res p o nse ( C R)  
➢ N o circ ulati n g blasts or e xtra me d ullar y  diseas e  
◼ N o l y m p ha de n o pat h y, s ple n o me gal y, s ki n/ g u m i nfiltrati o n/testic ular 
mass/ ce ntral ner v o us s yste m i n v ol ve me nt 
➢ Trili nea ge he m at o p oiesis a n d < 5 % blasts  
➢ A bs ol ute ne utr o p hil c o u nt ( A N C) > 1 0 0 0/ micr o L  
➢ Platelets > 1 0 0, 0 0 0/ micr o L  
➢ N o rec urre n ce f or 4 wee ks  
 
•  C R wit h i nc o m plete bl o o d c o u nt rec o v er y ( C Ri)  
➢ Meets all criteria f or C R e xce pt platelet  c o u nt a n d/ or A N C  
 
•  Refract or y disease  
➢ Fail ure t o a c hie ve C R at t he e n d of i n d ucti o n  
 
•  Pr o gressi v e disease  
➢ I n crease of at least 2 5 % i n t he a bs ol ute n u m ber of circ ulati n g or b o ne m arr o w blasts 
or de vel o p me nt of e xtra me d ullar y disease  
 
•  Rela pse d disease  
➢ Rea p peara nce of blasts i n t he bl o o d or b o ne marr o w ( > 5 %) or i n a n y e xtra me d ullar y 
site after a C R  
0 9 0 1 7 7 e 1 9f 6 5 3 3 e e\ Fi n al\ Fi n al O n: 0 7- D e c- 2 0 2 3 0 8: 1 9 ( G M T)