Study: NCT04148508

Adverse event: Hospitalisation for overnight stay
Serious: yes
Organ System: Psychiatric disorders
Notes: Participants hospitalised for mental health reasons for 1 or more nights. None of the participants reported their hospitalisation to be due to the intervention. The hospitalisations were identified by participant self-report at follow up.
Frequency: 5 affected / 847 at risk

Adverse event: Participant reported suicide risk at follow up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 1m follow up.
Frequency: 8 affected / 847 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 3m follow up.
Frequency: 7 affected / 847 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 12m follow up.
Frequency: 22 affected / 847 at risk

Adverse event: Hospitalisation for overnight stay
Serious: yes
Organ System: Psychiatric disorders
Notes: Participants hospitalised for mental health reasons for 1 or more nights. None of the participants reported their hospitalisation to be due to the intervention. The hospitalisations were identified by participant self-report at follow up.
Frequency: 8 affected / 841 at risk

Adverse event: Participant reported suicide risk at follow up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 1m follow up.
Frequency: 4 affected / 841 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 3m follow up.
Frequency: 10 affected / 841 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 12m follow up.
Frequency: 32 affected / 841 at risk

Adverse event: Hospitalisation for overnight stay
Serious: yes
Organ System: Psychiatric disorders
Notes: Participants hospitalised for mental health reasons for 1 or more nights. None of the participants reported their hospitalisation to be due to the intervention. The hospitalisations were identified by participant self-report at follow up.
Frequency: 1 affected / 844 at risk

Adverse event: Participant reported suicide risk at follow up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 1m follow up.
Frequency: 10 affected / 844 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 3m follow up.
Frequency: 19 affected / 844 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 12m follow up.
Frequency: 37 affected / 844 at risk

Adverse event: Hospitalisation for overnight stay
Serious: yes
Organ System: Psychiatric disorders
Notes: Participants hospitalised for mental health reasons for 1 or more nights. None of the participants reported their hospitalisation to be due to the intervention. The hospitalisations were identified by participant self-report at follow up.
Frequency: 8 affected / 417 at risk

Adverse event: Participant reported suicide risk at follow up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 1m follow up.
Frequency: 7 affected / 417 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 3m follow up.
Frequency: 13 affected / 417 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 12m follow up.
Frequency: 22 affected / 417 at risk

Adverse event: Hospitalisation for overnight stay
Serious: yes
Organ System: Psychiatric disorders
Notes: Participants hospitalised for mental health reasons for 1 or more nights. None of the participants reported their hospitalisation to be due to the intervention. The hospitalisations were identified by participant self-report at follow up.
Frequency: 15 affected / 423 at risk

Adverse event: Participant reported suicide risk at follow up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 1m follow up.
Frequency: 10 affected / 423 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 3m follow up.
Frequency: 16 affected / 423 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 12m follow up.
Frequency: 30 affected / 423 at risk

Adverse event: Hospitalisation for overnight stay
Serious: yes
Organ System: Psychiatric disorders
Notes: Participants hospitalised for mental health reasons for 1 or more nights. None of the participants reported their hospitalisation to be due to the intervention. The hospitalisations were identified by participant self-report at follow up.
Frequency: 8 affected / 422 at risk

Adverse event: Participant reported suicide risk at follow up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 1m follow up.
Frequency: 8 affected / 422 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 3m follow up.
Frequency: 17 affected / 422 at risk

Adverse event: Participant reported suicide risk at follow-up
Serious: no
Organ System: Psychiatric disorders
Notes: Participant replied yes to questions about either regular thoughts about suicide, intentions to hurt or kill themselves, or plans to harm themselves or end their life (in the previous 2 weeks). This was self-reported at 12m follow up.
Frequency: 24 affected / 422 at risk