Additional file 5: Table S5: Content of information and details in the clinical study reports

(1)

Additional file 5: Table S5: Content of information and details in the clinical study reports

Study ID Pag es

Redact ons*

Efficac y evalua

ton (E3 secto

n 11)

Table of Primar

y &

secon dary results

Safety evalua ton provid ed (E3 secto n 12)

Integrated summary of safety/concl

usions

Table of AEs/S

AEs

Incide nce thresh

old used in any group

Narrat ves for serious adverse events

or deaths

RIS-USA-72 174 High Yes Yes Yes No No

At least

5%

Remov ed from

CSR append

ix

RIS-BIM- 301

118 6

Mediu

m Yes Yes Yes Yes Yes

At least

5%

Remov ed from

CSR append

ix

RIS-SCH-

302 632 Low Yes Yes Yes Yes Yes

At least

5%

Yes (some informa

tion retracte

d)

RIS-BIP-302 385 9

Mediu

At least

2%

Remov ed from

CSR append

ix

RISBIM300 3

124 6

Mediu

At least

2%

Remov ed from

CSR append

ix

RIS-USA-

121 989 Mediu

At least

5%

Remov ed from

CSR append

(2)

ix

RIS-INT-69 114 1

Mediu

At least

5%

Remov ed from

CSR append

ix

RIS-USA-

239 389 Mediu

At least

5%

Remov ed from

CSR append

ix

RISBMN300 1

145 7

Mediu

At least

2%

Remov ed from

CSR append

ix

RIS-SCP-402 198 Mediu

At least

5%

Remov ed from

CSR append

ix

R076477-

SCH-304 700 Mediu

At least

5%

Remov ed from

CSR append

ix

R076477-

SCH-303 794 Mediu

At least

5%

Remov ed from

CSR append

ix

R076477-

SCH-302 599 Mediu

At least

5%

Remov ed from

CSR append

ix

R076477-

SCH-301 982 Low Yes Yes Yes Yes Yes

At least

5%

Yes (some informa

tion retracte

d)

R076477-

SCH-1010 431 Mediu

At least

5%

Remov ed from

CSR append

ix

(3)

R076477-

BIM-3001 554 Mediu

At least

5%

Remov ed from

CSR append

ix

R076477-

BIM-3003 473 Mediu

At least

5%

Remov ed from

CSR append

ix

R076477-

BIM-3002 797 Mediu

At least

5%

Remov ed from

CSR append

ix R076477SC

H3015

108

7 High Yes Yes Yes Yes Yes

At least

5%

No mentio

n

R076477SC A3001

208 4

Mediu

At least

5%

Remov ed from

CSR append

ix

R076477SC A3002

177 5

Mediu

At least

5%

Remov ed from

CSR append

ix

R076477- SCH-701

181 3

Mediu

At least

5%

Remov ed from

CSR append

ix R076477-

SCH-702 842 Low Yes Yes Yes Yes Yes

At least

5%

Yes

R092670-

SCH-201 771 Mediu

At least

2%

Remov ed from

CSR append

ix Remov

(4)

Y3001 m least 2%

ed from CSR append

ix

R092670PS

Y3003 844 High Yes Yes Yes Yes Yes

At least

2%

Remov ed from

CSR append

ix

R092670PS

Y3007 666 Mediu

At least

2%

Remov ed from

CSR append

ix

R092670SC A3004

133 8

Mediu

At least

2%

Remov ed from

CSR append

ix

PALM-JPN-

4 668 Mediu

At least

2%

Remov ed from

CSR append

ix

R092670PS Y3012

129 6

Mediu

At least

2%

Remov ed from

CSR append

ix

R076477PS

Z3001 825 Mediu

At least

5%

Remov ed from

CSR append

ix

R076477- SCH-3041

106 6

Mediu

At least

2%

Remov ed from

CSR append

ix

R076477-

SCH-305 182 Mediu

At least

5%

Remov ed from

CSR append

ix

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*Coding defined as: Low (i.e. only subject ID and PI names redacted); Moderate (i.e. identification of narratives and some pages being removed); High (i.e. pages were removed in the core report and/or some outcome data appears to have been redacted).

CSR: clinical study reports; AEs: adverse events; SAEs: Serious adverse events