Revision History

Revision History

© 2021 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Columbiathe Columbia-Suicide Severity Rating Scale Baseline Version 1/14/2009 (C-SSRS BASELINE) instrument.

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

...

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

...

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.  

2 Copyright Status

The Research Foundation for Mental Hygiene, Inc. owns the copyright for the C-SSRS BASELINE instrument BASELINE instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence Hence, CDISC developed QSTESTCD developed QSTESTCD and QSTEST for QSTEST for each item based on the actual text on the instrument.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

No part of the C-SSRS BASELINE Version 1/14/2009 may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of The Research Foundation for Mental Hygiene, Inc. and payment of any applicable fees. Copyright 2008 The Research Foundation for Mental Hygiene, Inc. All rights reserved.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges The Research Foundation for Mental Hygiene, Inc. for  for the approval to include the C-SSRS BASELINE in BASELINE in the CDISC data standards.

Reference for the C-SSRS BASELINE:

• (C-SSRS) Since Last Visit Version Baseline 1/14/2009 (Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; Burke, A.; Oquendo, M.; Mann, J.; copyright 2008 The Research Foundation for Mental Hygiene, Inc.) 
• No part of the C-SSRS SINCE LAST VISIT Version 1/14/2009 may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of The Research Foundation for Mental Hygiene, Inc. and payment of any applicable fees. Copyright 2008 The Research Foundation for Mental Hygiene, Inc. All rights reserved.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the Cthe C-SSRS BASELINE are listed below.

The C-SSRS SINCE LAST VISIT is BASELINE is a suicidal ideation rating scale. It 's a is a standard questionnaire administered on a CRF that is typically used in clinical trials to identify subjects at risk for suicidal ideation and behavior. 

1. The questionnaire is divided into 3 sections namely : Suicidal Ideation, Intensity of Ideation, and Suicidal Behavior.
   1. The first section, "SUICIDAL IDEATION"Suicidal Ideation, contains 5 items (.
      1. QSTESTCD = "
      CSS0201
      1. CSS0101" - "
      CSS0205
      1. CSS0105"
      )
      1. with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N".
         1. If QSORRES = "Yes", then descriptions
      are represented in items
      1. 1. provided for QSTESTCD = "CSS0101A" - "CSS0105A" are represented in QSORRES and QSSTRESC. QSSTRESN is null for these items.
   2. The second section "INTENSITY OF IDEATION" , Intensity of Ideation, contains 6 items (.
      1. QSTESTCD = "CSS0106"
      - "CSS0111")
      1.  is rating the most severe ideation with responses represented with a numeric
      score  (either "0-5" or "
      1. score (1-5
      "
      1. )
      and associated descriptive text. If "Most Severe
      1. in QSORRES, QSSTRESC, and QSSTRESN.
         1. "Description of Ideation" (QSTESTCD = "
      CSS0106
      1. 1. CSS0106A") is
      present, "Description of Ideation" (QSTESTCD = "CSS0106A") is collected as
      1. 1. collected as free text.
       For
      1. 1.  For this section of the C-SSRS BASELINE, QSORRES and QSSTRESC are represented with the text description. QSSTRESN is null for this item.
      2. For QSTESTCD = "CSS0107" - "CSS0108", the scale points include a numeric rating (1-5) and a definition of what is represented by the rating (e.g., 1 = "Less than once a week"). QSORRES is populated with the text description
      while
      1. ; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
      1.   
      2. For QSTESTCD = "CSS0109" - "CSS0111", the scale points include a numeric rating (0-5) and a definition of what is represented by the rating (e.g., 0 = "Does not attempt to control thoughts"). QSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
   3. The third section, Suicidal Behavior, contains 7 items.The third section, "SUICIDAL BEHAVIOR" contains 6 items (
      1. QSTESTCD = "CSS0112", "CSS0114", "CSS0115", "CSS0117", and "CSS0119"
      , and "CSS0120") with QSORRES
      1. with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". QSSTRESN is null.
         1. If QSORRES = "Yes", then descriptions
      are represented in items
      1. 1. provided for QSTESTCD = "CSS0113A", "CSS0116A", "CSS0118A", and "CSS0119A" are represented in QSORRES and QSSTRESC. QSSTRESN is null for these items.
      2. For QSTESTCD = "CSS0120" QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". QSSTRESN is null for these items.
      A
      2. "Total # of Attempts" (QSTESTCD = "CSS0113"), "Total # of interrupted" (QSTESTCD = "CSS0116") and "Total # of aborted" (QSTESTCD = "CSS0118") is
      collected
      1. represented in QSORRES, QSSTRESC, and QSSTRESN.
      2. The section "Answer for Actual Attempts Only" contains the following:
         1. "Most Recent Attempt Date" (CSS0121A), "Most Lethal Attempt Date" (QSTESTCD = "CSS0122A"), and "Initial/First Attempt Date" (CSS0123A)
      collected
      1. 1. are represented in QSORRES and QSSTRESC and should be in ISO 8601 format.
         2. "Actual Lethality/Medical Damage" for "Most Recent Attempt", "Most Lethal Attempt" and "Initial/First Attempt"
       
      1. 1. (QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B"), and "Potential Lethality" (QSTESTCD = "CSS0121C", "CSS0122C", and "CSS0123C") are represented with a numeric score (either "0-5" or "0-2", respectively) and descriptive text. For this section of the C-SSRS BASELINE, QSORRES is populated with the text description
      while
      1. 1. ; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
   4. The time period of evaluation for the C-SSRS BASELINE is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the C-SSRS BASELINE is "Lifetime: Time He/She Felt Most SuicidalLIFETIME" (QSEVINTX = "LIFETIME").
   5. Items are divided into 3 subcategories represented in QSSCAT: "SUICIDAL IDEATION", "INTENSITY OF IDEATION", and "SUICIDAL BEHAVIOR".
   6. Some items on the C-SSRS BASELINE may be not done due to conditional branching. Items determined for conditional branching in the Cthe C-SSRS BASELINE are as follows:
      1. If QSTESTCD = "CSS0101" and "CSS0102" have QSORRES = "No", then the logic branches to QSTESTCD = "CSS0112" and QSTESTCD = "CSS0103" - "CSS010111" will not be done.
      2. If QSTESTCD = "CSS0101" has QSORRES ="Yes" and QSTESTCD = "CSS0102" has QSORRES = "No", then the logic branches to QSTESTCD   = "CSS0112CSS0106" and QSTESTCD = "CSS0103" - "CSS0111CSS0105A" will not be done.
      3. Items QSTESTCD = "CSS0101A" - "CSS0105A" are only completed when the response to the preceding items (QSTESTCD = "CSS0101" - "CSS0105") is "Yes"; otherwise they are not done.
      4. If QSTESTCD = "CSS0112" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0114" and QSTESTCD = "CSS0113", "CSS0113A", "CSS0121A", "CSS0121B", "CSS0121C", "CSS0122A", "CSS0122B", "CSS0122C", and "CSS0123A", "CSS0123B", "CSS0123C", will not be done.
      5. If QSTESTCD = "CSS0115" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0117" and QSTESTCD = "CSS0116", and "CSS0116A" will not be done.
      6. If QSTESTCD = "CSS0117" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0119" and QSTESTCD = "CSS0118", and "CSS0118A" will not be done.
      7. If QSTESTCD = "CSS0119" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0120", and QSTESTCD = "CSS0119A" will not be done.
      8. If QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B" have QSORRES QSSTRESC = "1", "2", "3", "4", or "5", then QSTESTCD = "CSS0121C", "CSS0122C", and "CSS0123C" will not be done.

   7. A derived record is created and a QS supplemental qualifier variable is used to indicate an item was conditionally branched. When  When an item is not done due to conditional branching, it is represented as follows:

      1. QSDRVFL = "Y".

      2. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y” . (This is a QS supplemental qualifier variable.)      

      3. QSSTAT = "NOT DONE", and QSREASND is missing

      4. QSORRES, QSSTRESC, and QSSTRESN are set to null (missing)
   8. Records are created in qs.xpt for every item on the sponsor's version of the instrument.
      1. For items not done due to conditional branching, refer to assumptions 4 and 5.
      2. In the unexpected situation where the reason is unknown, then QSORRES, QSSTRESC and QSSTRESN are all missing, QSSTAT = "NOT DONE", and QSREASND is missing.

   9. Some responses to the C-SSRS SINCE LAST VISITBASELINE items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit. 

   10. Terminology

       1. QSCAT, QSTESTCD, and QSTEST values QSTEST values are included in CDISC Controlled Terminology.

       2. A full list of value sets for the qualifier, timing, and result fields  result fields is provided in Section 4, SDTM Mapping Strategy.

   3.2 Example for the C-SSRS BASELINE QS Domain Model

   The CThe C-SSRS BASELINE example below shows the terminology used to implement the instrument in the QS domainthe QS domain. This example shows the data for 1 subject collected at the baseline visit and baseline (v1) and another subject at baseline (v1) and visit 2 for the C2 for the C-SSRS BASELINE instrumentBASELINE instrument. The example uses CDISC Controlled Terminology for QSTESTCDfor QSTESTCD, QSTEST, and QSCAT. All  All original results, matching the CRF item response text, are represented in QSORRES. This in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and in QSSTRESN and as a standard character representation in QSSTRESC. When in QSSTRESC. When a result is character only, the result is transformed into the standard character representation in QSSTRESC and QSSTRESN is null.

   The table represents the items from the C-SSRS BASELINE instrumentBASELINE instrument.

   Dataset wrap
   Name qs
   rowcaps Dataset wrap Name qs qs.xpt Rows 13 5- 14 6: Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX". Rows 15-16: Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX". Row 33: The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF. Represent the conditional branching on data entry where Suicidal Ideation-No Intent is "No" and the associated description is missing. Rows 9-10: Represent the conditional branching on data entry where Ideation With Plan/Intent is "No" and the associated description is missing. Rows 28-29: Represent the conditional branching on data entry where Preparatory Acts/Behavior is "No" and the associated description is missing. Rows 32-33: Represent the conditional branching on data entry where Most Recent Attempt Damage is "3" and Most Recent Attempt Potential is missing. Rows 35-36: Represent the conditional branching on data entry where Most Lethal Attempt Damage is "4" and Most Lethal Attempt Potential is missing. Rows 40-56: Represents items missing due to conditional branching from the items Wish to be Dead and Non-Specific Suicidal Thought being "No". Rows 57-59: Represent the conditional branching on data entry where Actual Attempt is "No". The Number of Actual Attempts and the associated description are missing. Rows 61-63: Represent the conditional branching on data entry where Interrupted Attempt is "No". The Number of Interrupted Attempts and the associated description are missing. Rows 64-66: Represent the conditional branching on data entry where Aborted Attempt is "No". The Number of Aborted Attempt and the associated description are missing. Rows 70-78: Represents items missing due to conditional branching from Actual Attempt being "No". Rows 79-117: Show the subject was not evaluated on this instrument at visit 2. A record for each item on the instrument is created with a status of "NOT DONE". Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

   3

   Dataset2
   ROW STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN QSSTAT QSREASND QSLOBXFL VISITNUM QSDTC QSEVINTX 1
   Dataset2
   Row	STUDYID	DOMAIN	USUBJID	QSSEQ	QSTESTCD	QSTEST	QSCAT	QSSCAT	QSORRES	QSSTRESC	QSSTRESN	QSSTAT	QSREASND	QSLOBXFL	QSDRVFL	VISITNUM	QSDTC	QSEVINTX
   1	STUDYX	QS	2324-P0001	1	CSS0101	CSS01-Wish to be Dead	C-SSRS BASELINE	SUICIDAL IDEATION	Yes	Y	Y	1	08/19/2022	BASELINE	2	STUDYX	QS	2324-P0001	2	CSS0101A	CSS01-Wish to be Dead, Describe	C-SSRS BASELINE	SUICIDAL IDEATION	Fall asleep and not wake up	Fall asleep and not wake up	Y	1	08/19/2022	BASELINE

   STUDYX

   QS

   2324-P0001

   3

   1

   CSS0102

   CSS0101

   CSS01-

   Non-Specific Suicidal Thought

   Wish to be Dead

   C-SSRS BASELINE

   SUICIDAL IDEATION

   Yes

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   4

   2

   STUDYX

   QS

   2324-P0001

   4

   2

   CSS0102A

   CSS0101A

   CSS01-

   Non-Specific Suicid Thought, Descr

   Wish to be Dead, Describe

   C-SSRS BASELINE

   SUICIDAL IDEATION

   I thought about taking an overdose but I never made a specific plan as to whenI thought about taking an overdose but I never made a specific plan as to when

   Fall asleep and not wake up

   Fall asleep and not wake up

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   5

   3

   STUDYX

   QS

   2324-P0001

   5

   3

   CSS0103

   CSS0102

   CSS01-Non-Specific Suicidal

   Ideation-No Intent

   Thought

   C-SSRS BASELINE

   SUICIDAL IDEATION

   No

   Yes

   N

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   6

   4

   STUDYX

   QS

   2324-P0001

   6

   4

   CSS0103A

   CSS0102A

   CSS01-

   Suicidal Ideation-No Intent

   Non-Specific Suicid Thought, Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONEYY108/19/2022BASELINE

   I thought about taking an overdose but I never made a specific plan as to when	I thought about taking an overdose but I never made a specific plan as to when				Y	1	2022-08-19	LIFETIME
   5

   7

   STUDYX

   QS

   2324-P0001

   7

   5

   CSS0104

   CSS0103

   CSS01-Suicidal Ideation

   With

   -No Intent

   , No Plan

   C-SSRS BASELINE

   SUICIDAL IDEATION

   Yes

   No

   Y

   N

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   8

   6

   STUDYX

   QS

   2324-P0001

   8

   6

   CSS0104A

   CSS0103A

   CSS01-Suicidal Ideation

   With

   -No Intent

   No Plan Y

   , Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   I’ve thought about killing myself and howI’ve thought about killing myself and how

   NOT DONE

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   9

   7

   STUDYX

   QS

   2324-P0001

   9

   7

   CSS0105

   CSS0104

   CSS01-Ideation With Intent, No Plan

   /Intent

   C-SSRS BASELINE

   SUICIDAL IDEATION

   No

   Yes

   N

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   10

   8

   STUDYX

   QS

   2324-P0001

   10

   8

   CSS0105A

   CSS0104A

   CSS01-Ideation With Intent No Plan

   /Intent,

   Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   I’ve thought about killing myself and how

   I’ve thought about killing myself and how

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   11

   9

   STUDYX

   QS

   2324-P0001

   11

   9

   CSS0106

   CSS0105

   CSS01-

   Most Severe

   Ideation With Plan/Intent

   C-SSRS BASELINE

   INTENSITY OF

   SUICIDAL IDEATION

   11

   No

   1

   N

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   12

   10

   STUDYX

   QS

   2324-P0001

   12

   10

   CSS0106A

   CSS0105A

   CSS01-

   Most Severe

   Ideation With Plan/Intent,

   Description

   Descr

   C-SSRS BASELINE

   INTENSITY OF

   SUICIDAL IDEATION

   Wish to be DeadWish to be DeadY

   NOT DONE

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   13

   11

   STUDYX

   QS

   2324-P0001

   13

   11

   CSS0107

   CSS0106

   CSS01-Most Severe Ideation

   , Frequency

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Once a week

   1

   2

   1

   2

   1

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   14

   12

   STUDYX

   QS

   2324-P0001

   14

   12

   CSS0108

   CSS0106A

   CSS01-Most Severe Ideation,

   Duration

   Description

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   4-8 hours/most of day44

   Wish to be Dead

   Wish to be Dead

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   15

   13

   STUDYX

   QS

   2324-P0001

   15

   13

   CSS0109

   CSS0107

   CSS01-Most Severe Ideation,

   Control

   Frequency

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Does not attempt to control thoughts0

   Once a week

   2

   2

   0

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   16

   14

   STUDYX

   QS

   2324-P0001

   16

   14

   CSS0110

   CSS0108

   CSS01-Most Severe Ideation,

   Deterrents

   Duration

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Does not apply0

   4-8 hours/most of day

   4

   4

   0

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   17

   15

   STUDYX

   QS

   2324-P0001

   17

   15

   CSS0111

   CSS0109

   CSS01-Most Severe Ideation,

   Reasons

   Control

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Mostly to get attention, revenge or a reaction from others2

   Does not attempt to control thoughts

   0

   0

   2

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   18

   16

   STUDYX

   QS

   2324-P0001

   18

   16

   CSS0112

   CSS0110

   CSS01-

   Actual Attempt

   Most Severe Ideation, Deterrents

   C-SSRS BASELINE

   SUICIDAL BEHAVIORYes

   INTENSITY OF IDEATION

   Does not apply

   0

   0

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   19

   17

   STUDYX

   QS

   2324-P0001

   19

   17

   CSS0113

   CSS0111

   CSS01-

   Number of Actual Attempts

   Most Severe Ideation, Reasons

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR55

   INTENSITY OF IDEATION

   Mostly to get attention, revenge or a reaction from others

   2

   2

   5

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   20

   18

   STUDYX

   QS

   2324-P0001

   20

   18

   CSS0113A

   CSS0112

   CSS01-Actual Attempt

   , Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   To feel better

   Yes

   Y

   To feel better

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   21

   19

   STUDYX

   QS

   2324-P0001

   21

   19

   CSS0114

   CSS0113

   CSS01-

   Non-suicidal Self-injurious Behav

   Number of Actual Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   5

   No

   5

   N

   5

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   22

   20

   STUDYX

   QS

   2324-P0001

   22

   20

   CSS0115

   CSS0113A

   CSS01-

   Interrupted

   Actual Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   To feel better

   To feel better

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   23

   21

   STUDYX

   QS

   2324-P0001

   23

   21

   CSS0116

   CSS0114

   CSS01

   -Number of Interrupted Attempts

   -Non-suicidal Self-injurious Behav

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   1

   No

   1

   N

   1

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   24

   22

   STUDYX

   QS

   2324-P0001

   24

   22

   CSS0116A

   CSS0115

   CSS01-Interrupted Attempt

   , Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Stopped from overdose

   Yes

   Y

   Stopped from overdose

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   25

   23

   STUDYX

   QS

   2324-P0001

   25

   23

   CSS0117

   CSS0116

   CSS01-

   Aborted Attempt

   Number of Interrupted Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   1

   1

   Y

   1

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   26

   24

   STUDYX

   QS

   2324-P0001

   26

   24

   CSS0118

   CSS0116A

   CSS01-

   Number of Aborted Attempts

   Interrupted Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   33

   Stopped from overdose

   Stopped from overdose

   3

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   27

   25

   STUDYX

   QS

   2324-P0001

   27

   25

   CSS0118A

   CSS0117

   CSS01-Aborted Attempt

   , Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Parent found my letters

   Yes

   Y

   Parent found my letters

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   28

   26

   STUDYX

   QS

   2324-P0001

   28

   26

   CSS0119

   CSS0118

   CSS01-

   Preparatory Acts/Behavior

   Number of Aborted Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   3

   No

   3

   N

   3

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   29

   27

   STUDYX

   QS

   2324-P0001

   29

   27

   CSS0119A

   CSS0118A

   CSS01-

   Preparatory Acts/Behavior, Descr

   Aborted Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   Parent found my letters

   Parent found my letters

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   30

   28

   STUDYX

   QS

   2324-P0001

   30

   28

   CSS0120

   CSS0119

   CSS01-

   Suicidal

   Preparatory Acts/Behavior

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   No

   Y

   N

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   31

   29

   STUDYX

   QS

   2324-P0001

   31

   29

   CSS0121A

   CSS0119A

   CSS01-

   Most Recent Attempt DateY

   Preparatory Acts/Behavior, Descr

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   2/14/2016

   NOT DONE

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   32

   30

   STUDYX

   QS

   2324-P0001

   32

   30

   CSS0121B

   CSS0120

   CSS01-

   Most Recent Attempt Damage

   Suicidal Behavior

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Moderately severe physical damage; medical hospitalization and likely intensive care required33Y08/19/2022BASELINE

   Yes	Y				Y	1	2022-08-19	LIFETIME
   31

   33

   STUDYX

   QS

   2324-P0001

   33

   31

   CSS0121C

   CSS0121A

   CSS01-Most Recent Attempt

   Potential

   Date

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Behavior likely to result in death despite available medical care22Y08/19/2022BASELINE

   2022-07-17	2022-07-17				Y	1	2022-08-19	LIFETIME
   32

   34

   STUDYX

   QS

   2324-P0001

   34

   32

   CSS0122A

   CSS0121B

   CSS01-Most

   Lethal

   Recent Attempt

   Date

   Damage

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   12/31/2013

   Moderately severe physical damage; medical hospitalization and likely intensive care required

   3

   3

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   35

   33

   STUDYX

   QS

   2324-P0001

   35

   33

   CSS0122B

   CSS0121C

   CSS01-Most

   Lethal

   Recent Attempt

   Damage

   Potential

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Severe physical damage; medical hospitalization with intensive care required44Y08/19/2022BASELINE

   				NOT DONE			1	2022-08-19	LIFETIME
   34

   36

   STUDYX

   QS

   2324-P0001

   36

   34

   CSS0122C

   CSS0122A

   CSS01-Most Lethal Attempt

   Potential

   Date

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Behavior likely to result in death despite available medical care22Y08/19/2022BASELINE

   2021-12-24	2021-12-24				Y	1	2022-08-19	LIFETIME
   35

   37

   STUDYX

   QS

   2324-P0001

   37

   35

   CSS0123A

   CSS0122B

   CSS01-

   First

   Most Lethal Attempt

   Date

   Damage

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   3/27/2009

   Severe physical damage; medical hospitalization with intensive care required

   4

   4

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   38

   36

   STUDYX

   QS

   2324-P0001

   38

   36

   CSS0123B

   CSS0122C

   CSS01-

   First

   Most Lethal Attempt

   Damage

   Potential

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No physical damage or very minor physical damage00Y08/19/2022BASELINE

   			NOT DONE			1	2022-08-19	LIFETIME
   37

   39

   STUDYX

   QS

   2324-P0001

   39

   37

   CSS0123C

   CSS0123A

   CSS01-First Attempt

   Potential

   Date

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Behavior not likely to result in injury00Y08/19/2022BASELINE

   2017-02-14	2017-02-14				Y	1	2022-08-19	LIFETIME
   38

   40

   STUDYX

   QS

   2324-

   P0002

   P0001

   1

   38

   CSS0101

   CSS0123B

   CSS01-

   Wish to be Dead

   First Attempt Damage

   C-SSRS BASELINE

   SUICIDAL

   IDEATION

   BEHAVIOR

   No

   physical damage or very minor physical damage

   0

   0

   N

   Y

   1

   07/13/2022BASELINE

   2022-08-19	LIFETIME
   39

   41

   STUDYX

   QS

   2324-

   P0002

   P0001

   2

   39

   CSS0201A

   CSS0123C

   CSS01-

   Wish to be Dead, Describe

   First Attempt Potential

   C-SSRS BASELINE

   SUICIDAL

   IDEATIONNOT DONE

   BEHAVIOR

   Behavior not likely to result in injury

   0

   0

   Y

   Y

   1

   07/13/2022BASELINE

   2022-08-19	LIFETIME
   40

   42

   STUDYX

   QS

   2324-P0002

   3

   1

   CSS0102

   CSS0101

   CSS01-

   Non-Specific Suicidal Thought

   Wish to be Dead

   C-SSRS BASELINE

   SUICIDAL IDEATION

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   43

   41

   STUDYX

   QS

   2324-P0002

   4

   2

   CSS0102A

   CSS0101A

   CSS01-

   Non-Specific Suicid Thought, Descr

   Wish to be Dead, Describe

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   44

   42

   STUDYX

   QS

   2324-P0002

   5

   3

   CSS0103

   CSS0102

   CSS01-

   Suicidal Ideation-No Intent

   Non-Specific Suicidal Thought

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   No

   Y

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   …

   43

   …

   STUDYX

   …

   QS

   …

   2324-P0002

   …

   4

   ……………

   CSS0102A

   CSS01-Non-Specific Suicid Thought, Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   1

   2022-07-13

   LIFETIME

   44

   STUDYX

   QS

   2324-P0002

   5

   CSS0103

   CSS01-Suicidal Ideation-No Intent

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   1

   2022-07-13

   LIFETIME

   45

   …

   QS

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   ...

   56

   46

   STUDYX

   QS

   2324-P0002

   17

   CSS0111

   CSS01-Most Severe Ideation, Reasons

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   57

   47

   STUDYX

   QS

   2324-P0002

   18

   CSS0112

   CSS01-Actual Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   58

   48

   STUDYX

   QS

   2324-P0002

   19

   CSS0113

   CSS01-Number of Actual Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   59

   49

   STUDYX

   QS

   2324-P0002

   20

   CSS0113A

   CSS01-Actual Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   60

   50

   STUDYX

   QS

   2324-P0002

   21

   CSS0114

   CSS01-Non-suicidal Self-injurious Behav

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   61

   51

   STUDYX

   QS

   2324-P0002

   22

   CSS0115

   CSS01-Interrupted Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   62

   52

   STUDYX

   QS

   2324-P0002

   23

   CSS0116

   CSS01-Number of Interrupted Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   63

   53

   STUDYX

   QS

   2324-P0002

   24

   CSS0116A

   CSS01-Interrupted Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   64

   54

   STUDYX

   QS

   2324-P0002

   25

   CSS0117

   CSS01-Aborted Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   65

   55

   STUDYX

   QS

   2324-P0002

   26

   CSS0118

   CSS01-Number of Aborted Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   66

   56

   STUDYX

   QS

   2324-P0002

   27

   CSS0118A

   CSS01-Aborted Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   67

   57

   STUDYX

   QS

   2324-P0002

   28

   CSS0119

   CSS01-Preparatory Acts/Behavior

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   Y

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   68

   58

   STUDYX

   QS

   2324-P0002

   29

   CSS0119A

   CSS01-Preparatory Acts/Behavior, Descr

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Bought pills, Bought a gun, suicide note

   Bought pills, Bought a gun, suicide note

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   69

   59

   STUDYX

   QS

   2324-P0002

   30

   CSS0120

   CSS01-Suicidal Behavior

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   Y

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   70

   60

   STUDYX

   QS

   2324-P0002

   31

   CSS0121A

   CSS01-Most Recent Attempt Date

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   71

   61

   STUDYX

   QS

   2324-P0002

   32

   CSS0121B

   CSS01-Most Recent Attempt Damage

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   72

   62

   STUDYX

   QS

   2324-P0002

   33

   CSS0121C

   CSS01-Most Recent Attempt Potential

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   YY107/13/2022

   		1	2022-07-13	LIFETIME
   63

   BASELINE

   …

   …

   QS

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   78

   64

   STUDYX

   QS

   2324-P0002

   39

   CSS0123C

   CSS01-First Attempt Potential

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   07/13/2022BASELINE79

   65

   STUDYX

   QS

   2324-P0002

   40

   CSS0101

   CSS01-Wish to be Dead

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   80

   66	STUDYX	QS	2324-P0002	41

   CSS0201A

   CSS0101A

   CSS01-Wish to be Dead, Describe

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   81

   67

   STUDYX

   QS

   2324-P0002

   42

   CSS0102

   CSS01-Non-Specific Suicidal Thought

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   82

   68

   STUDYX

   QS

   2324-P0002

   43

   CSS0102A

   CSS01-Non-Specific Suicid Thought, Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   83

   69

   STUDYX

   QS

   2324-P0002

   44

   CSS0103

   CSS01-Suicidal Ideation-No Intent

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   …

   70	…

   …

   QS

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   117

   71	STUDYX	QS	2324-P0002	78

   CSS0123C

   CSS0103C

   CSS01-First Attempt Potential

   C-SSRS BASELINE

   SUICIDAL

   BEHAVIOR

   IDEATION

   NOT DONE

   2