Study: NCT02556606

Adverse event: Gastrointestinal complaints
Serious: no
Organ System: Gastrointestinal disorders
Notes: Using the Patient Reported Inventory of Side Effects (PRISE) as a score of 1 or 2 (mild to moderate adverse event); scores over 2 indicate serious adverse event and are not reported in this section. Collected to day 7 due to smaller sample to day 28.
Frequency: 4 affected / 4 at risk

Adverse event: Cardiac complaints
Serious: no
Organ System: Cardiac disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 1 affected / 4 at risk

Adverse event: Skin complaints
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 4 affected / 4 at risk

Adverse event: Nervous system complaints
Serious: no
Organ System: Nervous system disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 4 affected / 4 at risk

Adverse event: Eye or ear complaints
Serious: no
Organ System: Eye disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 3 affected / 4 at risk

Adverse event: Genital or urinary complaints
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 2 affected / 4 at risk

Adverse event: Sleep complaints
Serious: no
Organ System: General disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 4 affected / 4 at risk

Adverse event: Sexual functioning complaints
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 3 affected / 4 at risk

Adverse event: Other complaints
Serious: no
Organ System: General disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 4 affected / 4 at risk

Adverse event: Gastrointestinal complaints
Serious: no
Organ System: Gastrointestinal disorders
Notes: Using the Patient Reported Inventory of Side Effects (PRISE) as a score of 1 or 2 (mild to moderate adverse event); scores over 2 indicate serious adverse event and are not reported in this section. Collected to day 7 due to smaller sample to day 28.
Frequency: 4 affected / 5 at risk

Adverse event: Cardiac complaints
Serious: no
Organ System: Cardiac disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 3 affected / 5 at risk

Adverse event: Skin complaints
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 5 affected / 5 at risk

Adverse event: Nervous system complaints
Serious: no
Organ System: Nervous system disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 5 affected / 5 at risk

Adverse event: Eye or ear complaints
Serious: no
Organ System: Eye disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 5 affected / 5 at risk

Adverse event: Genital or urinary complaints
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 3 affected / 5 at risk

Adverse event: Sleep complaints
Serious: no
Organ System: General disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 5 affected / 5 at risk

Adverse event: Sexual functioning complaints
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 4 affected / 5 at risk

Adverse event: Other complaints
Serious: no
Organ System: General disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 5 affected / 5 at risk

Adverse event: Gastrointestinal complaints
Serious: no
Organ System: Gastrointestinal disorders
Notes: Using the Patient Reported Inventory of Side Effects (PRISE) as a score of 1 or 2 (mild to moderate adverse event); scores over 2 indicate serious adverse event and are not reported in this section. Collected to day 7 due to smaller sample to day 28.
Frequency: 8 affected / 11 at risk

Adverse event: Cardiac complaints
Serious: no
Organ System: Cardiac disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 4 affected / 11 at risk

Adverse event: Skin complaints
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 7 affected / 11 at risk

Adverse event: Nervous system complaints
Serious: no
Organ System: Nervous system disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 7 affected / 11 at risk

Adverse event: Eye or ear complaints
Serious: no
Organ System: Eye disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 4 affected / 11 at risk

Adverse event: Genital or urinary complaints
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 5 affected / 11 at risk

Adverse event: Sleep complaints
Serious: no
Organ System: General disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 11 affected / 11 at risk

Adverse event: Sexual functioning complaints
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 9 affected / 11 at risk

Adverse event: Other complaints
Serious: no
Organ System: General disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 11 affected / 11 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant made a suicide attempt four days after midazolam infusion. The event was determined unrelated to the intervention because this participant scored zero on the Columbia Suicide Severity Rating Scale one day before the attempt
Frequency: 1 affected / 13 at risk

Adverse event: Gastrointestinal complaints
Serious: no
Organ System: Gastrointestinal disorders
Notes: Using the Patient Reported Inventory of Side Effects (PRISE) as a score of 1 or 2 (mild to moderate adverse event); scores over 2 indicate serious adverse event and are not reported in this section. Collected to day 7 due to smaller sample to day 28.
Frequency: 11 affected / 13 at risk

Adverse event: Cardiac complaints
Serious: no
Organ System: Cardiac disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 7 affected / 13 at risk

Adverse event: Skin complaints
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 9 affected / 13 at risk

Adverse event: Nervous system complaints
Serious: no
Organ System: Nervous system disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 11 affected / 13 at risk

Adverse event: Eye or ear complaints
Serious: no
Organ System: Eye disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 11 affected / 13 at risk

Adverse event: Genital or urinary complaints
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 6 affected / 13 at risk

Adverse event: Sleep complaints
Serious: no
Organ System: General disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 13 affected / 13 at risk

Adverse event: Sexual functioning complaints
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 12 affected / 13 at risk

Adverse event: Other complaints
Serious: no
Organ System: General disorders
Notes: Collected with the Patient Reported Inventory of Side Effects (PRISE)
Frequency: 13 affected / 13 at risk