Study: NCT02849652

Adverse event: ORG0010
Serious: yes
Organ System: Psychiatric disorders
Notes: On 3/15/2017, ORG0010 was reportedly hospitalized for a duration of 30 days due to a psychotic episode and hearing voices. We were informed of this information from the participant on 6/5/2017, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0008
Serious: yes
Organ System: Psychiatric disorders
Notes: On 4/13/2017, ORG0008 was reportedly hospitalized for a duration of 5 days due to a psychotic episode. We were informed of this information from the participant on 6/8/2017, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0029
Serious: yes
Organ System: Psychiatric disorders
Notes: On 5/10/2017, ORG0029 was reportedly hospitalized for a duration of 1 day due to a psychotic episode. We were informed of this information from the participant on 6/8/2017, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0079
Serious: yes
Organ System: Psychiatric disorders
Notes: On 5/29/2017, ORG0079 was reportedly hospitalized for a duration of 19 days due to a psychotic episode. We were informed of this information from the participant on 6/22/2017, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0012
Serious: yes
Organ System: Psychiatric disorders
Notes: On 6/22/2017, ORG0012 was reportedly hospitalized for a duration of 7 days due to a psychotic episode. We were informed of this information from the participant on 10/4/2017, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0019
Serious: yes
Organ System: Psychiatric disorders
Notes: On 9/1/2017, ORG0019 was reportedly hospitalized for a duration of 30 days due to a psychotic episode. We were informed of this information from the participant on 10/3/2017, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0022
Serious: yes
Organ System: Psychiatric disorders
Notes: On 9/8/2017, ORG0022 was reportedly hospitalized for a duration of 14 days due to suicidal thoughts or behaviors. We were informed of this information from the participant on 10/9/2017, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0013
Serious: yes
Organ System: Psychiatric disorders
Notes: On 9/10/2017, ORG0013 was reportedly hospitalized for a duration of 4 days due to "a high anxiety level". We were informed of this information from the participant on 10/5/2017, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0327
Serious: yes
Organ System: General disorders
Notes: On 9/15/2017, ORG0327 was reportedly hospitalized for a duration of 7 days due to a drug or alcohol overdose. We were informed of this information from the participant on 5/22/2018, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0346
Serious: yes
Organ System: Psychiatric disorders
Notes: On 10/25/2017, ORG0346 was reportedly hospitalized for a duration of 11 days due to a psychotic episode.

On 6/5/2018, ORG0346 was reportedly hospitalized for a duration of 21 days for "drug rehab and depression".
Frequency: 1 affected / 344 at risk

Adverse event: ORG0198
Serious: yes
Organ System: Psychiatric disorders
Notes: On 10/28/2017, ORG0198 was reportedly hospitalized for a duration of 2 days due to a psychotic episode. We were informed of this information from the participant on 11/14/2017, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0299
Serious: yes
Organ System: General disorders
Notes: On 1/16/2018, ORG0299 was reportedly hospitalized for a duration of 28 days due to alcohol use. We were informed of this information from the participant on 5/21/2018, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0162
Serious: yes
Organ System: Psychiatric disorders
Notes: On 2/2/2018, ORG0162 was reportedly hospitalized for a duration of 7 days due to homicidal or aggressive behavior. We were informed of this information from the participant on 2/12/2018, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0305
Serious: yes
Organ System: Psychiatric disorders
Notes: On 1/15/2018, ORG0305 was reportedly hospitalized for a duration of 21 days due to a psychotic episode. We were informed of this information from the participant on 9/17/2018, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0415
Serious: yes
Organ System: General disorders
Notes: On 5/21/2018, ORG0415 was reportedly hospitalized for a duration of 30 days due to an unknown reason.

On 5/21/2018, ORG0415 was reportedly hospitalized for a duration of 14 days due to suicidal thoughts or behavior.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0374
Serious: yes
Organ System: Psychiatric disorders
Notes: On 2/15/2018, ORG0374 was reportedly hospitalized for a duration of 6 days due to self-harm.

On 9/15/2018, ORG0374 was reportedly hospitalized for a duration of 6 days due to suicidal thoughts or behavior.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0348
Serious: yes
Organ System: Psychiatric disorders
Notes: On 4/15/2018, ORG0348 was reportedly hospitalized for a duration of 28 days due suicidal thoughts or behavior.

On 9/24/2018, ORG0348 was reportedly hospitalized for a duration of 21 day due to a psychotic episode.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0390
Serious: yes
Organ System: Psychiatric disorders
Notes: On 4/26/2018, ORG0390 was reportedly hospitalized for a duration of 14 days due to suicidal thoughts or behavior. On 6/29/2018, ORG0390 was reportedly hospitalized for a duration of 7 days due to an unknown reason
Frequency: 1 affected / 344 at risk

Adverse event: ORG0426
Serious: yes
Organ System: General disorders
Notes: On 6/13/2018, ORG0426 was reportedly hospitalized for a duration of 1 day due to "medication change". We were informed of this information from the participant on 10/23/2018, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0362
Serious: yes
Organ System: General disorders
Notes: On 7/15/2018, ORG0362 was reportedly hospitalized for a duration of 21 days due to an unknown reason. We were informed of this information from the participant on 10/16/2018, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0367
Serious: yes
Organ System: Psychiatric disorders
Notes: On 8/5/2018, ORG0367 was reportedly hospitalized for a duration of 30 days due to suicidal thoughts or behavior. We were informed of this information from the participant on 2/14/2019, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0380
Serious: yes
Organ System: Psychiatric disorders
Notes: On 8/16/2018, ORG0380 was reportedly hospitalized for a duration of 33 days due to a psychotic episode. We were informed of this information from the participant on 10/15/2018, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0364
Serious: yes
Organ System: Psychiatric disorders
Notes: On 9/8/2018, ORG0364 was reportedly hospitalized for a duration of 6 days due to homicidal or aggressive behavior. We were informed of this information from the participant on 10/15/2018, during their Week 36 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0372
Serious: yes
Organ System: Psychiatric disorders
Notes: On 10/2/2018, ORG0372 was reportedly hospitalized for a duration of 7 days due to suicidal thoughts or behaviors.

On 1/15/2019, ORG0372 was reportedly hospitalized for a duration of 7 days due to suicidal thoughts or behaviors.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0421
Serious: yes
Organ System: Psychiatric disorders
Notes: On 10/10/2018, ORG0421 was reportedly hospitalized for a duration of 5 days due to a psychotic episode.

On 11/7/2018, ORG0421 was reportedly hospitalized for a duration of 23 days "to be put on medication".
Frequency: 1 affected / 344 at risk

Adverse event: ORG0389
Serious: yes
Organ System: Psychiatric disorders
Notes: On 12/25/2018, ORG0389 was reportedly hospitalized for a duration of 5 days due to a psychotic episode. We were informed of this information from the participant on 2/13/2019, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0425
Serious: yes
Organ System: General disorders
Notes: On 2/6/2019, ORG0425 was reportedly hospitalized for a duration of 7 days due to "drug rehab". We were informed of this information from the participant on 2/13/2019, during their Week 52 visit.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0620
Serious: yes
Organ System: Psychiatric disorders
Notes: they reported they were hospitalized on 12/10/2019 for 30 days for a psychotic episode. they reported they were hospitalized on 9/15/2019 for 2 days for a medication adjustment. They were also hospitalized on 6/15/2019 for 7 days for the same reason.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0705
Serious: yes
Organ System: Psychiatric disorders
Notes: During ORG0705 Week 36 session, they reported they were hospitalized on 9/26/2019 for 9 days for self-harm.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0759
Serious: yes
Organ System: Psychiatric disorders
Notes: During ORG0759 Week 36 session, they reported they were hospitalized on 1/15/2020 for 14 days for a psychotic episode.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0619
Serious: yes
Organ System: General disorders
Notes: On 3/26/2020, we were informed that ORG0619 is in rehab for an unknown duration.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0740
Serious: yes
Organ System: General disorders
Notes: During ORG0740 Week 36 session, they reported they were hospitalized on 7/25/2019 for 16 days for an unknown reason
Frequency: 1 affected / 344 at risk

Adverse event: ORG0727
Serious: yes
Organ System: Psychiatric disorders
Notes: During ORG0727 Week 36 session, they reported they were hospitalized on 12/3/2019 for 14 days for a psychotic episode.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0772
Serious: yes
Organ System: General disorders
Notes: On 05/14/2020, we were informed that ORG0772 was in the hospital due to COVID-19 complications.
Frequency: 1 affected / 344 at risk

Adverse event: ORG0098
Serious: yes
Organ System: Psychiatric disorders
Notes: On 11/25/2016, ORG0098 was reportedly hospitalized for a duration of 12 days due to suicidal thoughts or behaviors.

On 3/15/2017, ORG0098 was reportedly hospitalized for a duration of 7 days due to suicidal thoughts or behaviors.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0084
Serious: yes
Organ System: Psychiatric disorders
Notes: On 1/15/2017, ORG0084 was reportedly hospitalized for a duration of 14 days due to suicidal thoughts or behaviors. We were informed of this information from the participant on 7/13/2017, during their Week 36 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0093
Serious: yes
Organ System: Psychiatric disorders
Notes: On 2/4/2017, ORG0093 was reportedly hospitalized for a duration of 10 days due to suicidal thoughts or behaviors. We were informed of this information from the participant on 7/18/2017, during their Week 36 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0087
Serious: yes
Organ System: Psychiatric disorders
Notes: On 4/4/2017, ORG0087 was reportedly hospitalized for a duration of 9 days due to a psychotic episode. We were informed of this information from the participant on 7/19/2017, during their Week 36 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG101
Serious: yes
Organ System: Psychiatric disorders
Notes: On 6/15/2017, ORG0101 was reportedly hospitalized for a duration of 1 day due to suicidal thoughts or behaviors. We were informed of this information from the participant on 7/18/2017, during their Week 36 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0246
Serious: yes
Organ System: Psychiatric disorders
Notes: On 9/15/2017, ORG0246 was reportedly hospitalized for a duration of 5 days due to suicidal thoughts or behavior. We were informed of this information from the participant on 3/19/2018, during their Week 36 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0203
Serious: yes
Organ System: Psychiatric disorders
Notes: On 4/11/2018, ORG0203 was reportedly hospitalized for a duration of 8 days due to suicidal thoughts or behavior. We were informed of this information from the participant on 6/26/2018, during their Week 52 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0487
Serious: yes
Organ System: General disorders
Notes: On 9/1/2018, ORG0487 was reportedly hospitalized for a duration of 14 days due to a drug or alcohol overdose. We were informed of this information from the participant on 1/8/2019, during their Week 36 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0475
Serious: yes
Organ System: General disorders
Notes: On 2/27/2019, ORG0475 was reportedly hospitalized for a duration of 28 days due to an unknown reason. We were informed of this information from the participant on 4/17/2019, during their Week 52 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0479
Serious: yes
Organ System: Psychiatric disorders
Notes: On 4/6/2019, ORG0479 was reportedly hospitalized for a duration of 13 days due to a psychotic episode. We were informed of this information from the participant on 4/18/2019, during their Week 52 visit.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0922
Serious: yes
Organ System: Gastrointestinal disorders
Notes: On 11/23/2020, during the ORG0922 baseline session ppt expressed that he had been in the hospital for 12 days problems going to the bathroom.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0881
Serious: yes
Organ System: General disorders
Notes: On 3/18/2021 during the Week 12 session, ORG0881 informed a research team member that they were in the hospital from 2/18/2021-3/10/2021 due to being "302'd" (involuntarily admitted) by their sister and for having Covid-19.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0920
Serious: yes
Organ System: Social circumstances
Notes: On 5/26/2021 during the Week 24 session, ORG0920 reported that she'd been in a car accident on 5/17/21. As of 5/26 she is still in the hospital and cannot walk, but she is getting physical therapy.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0880
Serious: yes
Organ System: Renal and urinary disorders
Notes: On 8/18/2021 ORG0880 reported that she had been hospitalized on 7/24/2021 for a kidney infection. She spent 5 days at the hospital before being transferred to Immaculate Mary for inpatient rehab, which ended on 8/12/2021.
Frequency: 1 affected / 266 at risk

Adverse event: ORG0101
Serious: yes
Organ System: Psychiatric disorders
Notes: On 6/15/2017, ORG0101 was reportedly hospitalized for a duration of 1 day due to suicidal thoughts or behaviors. We were informed of this information from the participant on 7/18/2017, during their Week 36 visit.
Frequency: 1 affected / 266 at risk