Study: NCT04527146

Adverse event: Impact of Events IES-R
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (IES-R: above 33 point cutpoint).
Frequency: 5 affected / 94 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (GDS: Above 5 point cutpoint)
Frequency: 33 affected / 94 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (STAI: Above 40 on either sub scale)
Frequency: 45 affected / 94 at risk

Adverse event: Impact of Events IES-R
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (IES-R: above 33 point cutpoint).
Frequency: 7 affected / 91 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (GDS: Above 5 point cutpoint)
Frequency: 26 affected / 91 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (STAI: Above 40 on either sub scale)
Frequency: 49 affected / 91 at risk

Adverse event: Impact of Events IES-R
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (IES-R: above 33 point cutpoint).
Frequency: 2 affected / 92 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (GDS: Above 5 point cutpoint)
Frequency: 29 affected / 92 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (STAI: Above 40 on either sub scale)
Frequency: 46 affected / 92 at risk

Adverse event: Medical event unrelated to study
Serious: no
Organ System: General disorders
Notes: Medical event during study visit that was unrelated to study
Frequency: 1 affected / 92 at risk

Adverse event: Impact of Events IES-R
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (IES-R: above 33 point cutpoint).
Frequency: 6 affected / 93 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (GDS: Above 5 point cutpoint)
Frequency: 27 affected / 93 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (STAI: Above 40 on either sub scale)
Frequency: 50 affected / 93 at risk