Study: NCT04896593

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 22 at risk

Adverse event: Inpatient hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 22 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Increase in anger
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Increase in SIQ-Jr total score above threshold
Serious: no
Organ System: Psychiatric disorders
Notes: Increase in SIQ-Jr total score above reliable change threshold
Frequency: 3 affected / 22 at risk

Adverse event: Increased fatigue in swimming
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Sinus issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Feeling more down
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling more down due to increased swim and school demands
Frequency: 1 affected / 22 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: 10lb weight gain at the end of swim season
Frequency: 1 affected / 22 at risk

Adverse event: Medication side effects
Serious: no
Organ System: Psychiatric disorders
Notes: Side effects after stopped taking psychiatric medications
Frequency: 1 affected / 22 at risk

Adverse event: Increased mania
Serious: no
Organ System: Psychiatric disorders
Notes: Increased mania, frequently leaving house against parental wishes, discontinued psychiatric medications
Frequency: 1 affected / 22 at risk

Adverse event: Sexual abuse
Serious: no
Organ System: Social circumstances
Notes: Reported sexual assault to police and study IE
Frequency: 1 affected / 22 at risk

Adverse event: Thoughts of self-harm
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 22 at risk

Adverse event: ER and Urgent Care visits for migraines and vomiting.
Serious: no
Organ System: General disorders
Notes: Increased migraines and anxiety, vomiting due to migraines. Having hard time going to school and seeing friends. Went to the ER 3 times and Urgent Care 2 times, not admitted to hospital due to migraines/vomiting
Frequency: 1 affected / 22 at risk

Adverse event: ER visit for dizziness and not eating or drinking
Serious: no
Organ System: General disorders
Notes: Transferred from psychiatric inpatient to ER for dizziness and not eating or drinking
Frequency: 1 affected / 22 at risk

Adverse event: COVID-19+
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: ER visit for vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Increased stress, DCF involvement
Serious: no
Organ System: Psychiatric disorders
Notes: Increased stress, patient escorted home after spending the night outside of the home. DCF involved afterwards.
Frequency: 1 affected / 22 at risk

Adverse event: ER visit due to allergic reaction
Serious: no
Organ System: Immune system disorders
Notes: Accidental ingestion of nuts (has severe nut allergy), used epi pen. Went to ER and given steroid and Pepcid before discharged. No hospitalization.
Frequency: 1 affected / 22 at risk

Adverse event: Viral respiratory infection
Serious: no
Organ System: Infections and infestations
Notes: Not COVID/strep
Frequency: 1 affected / 22 at risk

Adverse event: Passive suicidal ideation, feeling more down
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: ER visit for suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk