Study: NCT02720016

Adverse event: Emergency room visit
Serious: no
Organ System: General disorders
Notes: Unrelated to study. Same-day discharge from ER.
Frequency: 2 affected / 92 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Notes: Unrelated to study
Frequency: 3 affected / 92 at risk

Adverse event: Surgery
Serious: no
Organ System: General disorders
Notes: Unrelated to study
Frequency: 1 affected / 92 at risk

Adverse event: APC Report
Serious: no
Organ System: Social circumstances
Notes: Unrelated to study. Mandated report.
Frequency: 1 affected / 92 at risk

Adverse event: Protocol Deviation
Serious: no
Organ System: Investigations
Notes: Total of 2 protocol deviations reported (unrelated to study).

1. Participant incarcerated during therapy due to parole violation.
2. Participant escorted by VA police for psychiatric evaluation for damaging the wall.
Frequency: 1 affected / 92 at risk

Adverse event: Emergency room visit
Serious: no
Organ System: General disorders
Notes: Unrelated to study. Same-day discharge from ER.
Frequency: 1 affected / 92 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Notes: Unrelated to study
Frequency: 3 affected / 92 at risk

Adverse event: Surgery
Serious: no
Organ System: General disorders
Notes: Unrelated to study
Frequency: 1 affected / 92 at risk

Adverse event: APC Report
Serious: no
Organ System: Social circumstances
Notes: Unrelated to study. Mandated report.
Frequency: 1 affected / 92 at risk

Adverse event: CPS Report
Serious: no
Organ System: Social circumstances
Notes: Unrelated to study. Mandated report.
Frequency: 2 affected / 92 at risk

Adverse event: Police visit
Serious: no
Organ System: Investigations
Notes: Unrelated to study. One incident where police visited participant's home due to noise complaint from domestic argument.
Frequency: 1 affected / 92 at risk

Adverse event: Protocol Deviation
Serious: no
Organ System: Investigations
Notes: Total of 2 protocol deviations reported (unrelated to study).

1. Participant incarcerated during therapy due to parole violation.
2. Participant escorted by VA police for psychiatric evaluation for damaging the wall.
Frequency: 1 affected / 92 at risk

Adverse event: Protocol Deviation-COVID-19
Serious: no
Organ System: General disorders
Notes: Unrelated to study. Due to the COVID-19 pandemic shutdown in San Diego, a total of 10 participants (5 couples) received home-based telehealth treatment despite being randomized to an office-based condition.
Frequency: 4 affected / 92 at risk

Adverse event: Emergency room visit
Serious: no
Organ System: General disorders
Notes: Unrelated to study. Same-day discharge from ER.
Frequency: 3 affected / 90 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Notes: Unrelated to study
Frequency: 2 affected / 90 at risk

Adverse event: APC Report
Serious: no
Organ System: Social circumstances
Notes: Unrelated to study. Mandated report.
Frequency: 3 affected / 90 at risk

Adverse event: Protocol Deviation-COVID-19
Serious: no
Organ System: General disorders
Notes: Unrelated to study. Due to the COVID-19 pandemic shutdown in San Diego, a total of 10 participants (5 couples) received home-based telehealth treatment despite being randomized to an office-based condition.
Frequency: 6 affected / 90 at risk