{
 "note": "Added in the correction, after the results were known and in answer to review. For every adverse-event group whose distinct participants with an outcome the posted tables leave open (results/ambiguous.csv), the trial's public reports were searched, whichever arm the group is in, for how many participants had the outcome's events: the trial's publication, the FDA's or another regulator's review, or the sponsor's documents. Each entry gives the bounds those reports leave, which lie within the tables' bounds, how they settle it ('statement': a report says which events were one participant's; 'count': a report counts the distinct participants; 'elimination': reports of pooled trials leave one possibility), and what they say. Groups no report settles keep the tables' bounds.",
 "groups": [
  {
   "comparison": "NCT01034462#1",
   "group": "EG001",
   "arm": "antidepressant",
   "title": "Levomilnacipran ER (LVM-MD-03)",
   "outcomes": {
    "S1": [
     1,
     1
    ],
    "S15": [
     1,
     1
    ],
    "S3": [
     2,
     3
    ]
   },
   "basis": "statement",
   "sources": [
    {
     "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4047313/",
     "says": "One levomilnacipran ER patient had suicidal behavior during the double-blind treatment; this incident was also reported as an SAE of intentional overdose/suicide attempt."
    },
    {
     "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000MedR.pdf",
     "says": "Table 59 lists subject 0670303 (Study LVM-MD-03) with both Intentional overdose and Suicide attempt, on day 9."
    },
    {
     "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4047313/",
     "says": "The SAEs in 2 patients during the down-taper period were hypertension/noncardiac chest pain and suicidal ideation; both were in the levomilnacipran ER group."
    }
   ],
   "note": "The intentional overdose and the suicide attempt are one participant. The registry lists suicidal ideation for 2 participants here; the paper and the FDA review give 1, a participant other than the one with the attempt, so any serious suicidality is 2 or 3."
  },
  {
   "comparison": "NCT01140906#1",
   "group": "EG003",
   "arm": "antidepressant",
   "title": "Duloxetine 60 mg (13267A)",
   "outcomes": {
    "S1": [
     1,
     1
    ],
    "S15": [
     1,
     1
    ],
    "S3": [
     1,
     1
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC3979887/",
     "says": "Two patients took an intentional overdose of zolpidem (vortioxetine group) or zolpidem and lormetazepam (duloxetine group). ... Two patients (one in each of the vortioxetine 20 mg and duloxetine groups) had serious AEs related to suicidal behaviour and self-harm."
    }
   ],
   "note": "One participant in this group had serious events related to suicidal behaviour and self-harm, so the intentional overdose and the self-injurious behaviour the registry lists are that participant's."
  },
  {
   "comparison": "NCT01456936#1",
   "group": "EG003",
   "arm": "placebo",
   "title": "Placebo (EAGLES)",
   "outcomes": {
    "S1": [
     2,
     3
    ],
    "S15": [
     2,
     3
    ],
    "S3": [
     5,
     6
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://web.archive.org/web/20161019101012/http://www.fda.gov:80/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM520105.pdf",
     "says": "Table 15, serious adverse events in the neuropsychiatric endpoint: non-psychiatric cohort 'placebo-Suicidal ideation (2), Completed suicide'; psychiatric cohort 'placebo-Suicide attempt, Suicidal ideation, Aggression'. Terms of one participant are joined by 'plus'."
    }
   ],
   "note": "The completed suicide, the suicide attempt and the three participants with suicidal ideation are five different participants. The registry's one serious event of suicidal behaviour, rated mild, is outside that list, so it may be one of them or a sixth."
  },
  {
   "comparison": "NCT01456936#1",
   "group": "EG001",
   "arm": "antidepressant",
   "title": "Bupropion (EAGLES)",
   "outcomes": {
    "S15": [
     3,
     3
    ],
    "S3": [
     2,
     3
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://web.archive.org/web/20161019101012/http://www.fda.gov:80/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM520105.pdf",
     "says": "Non-psychiatric cohort: 'suicidal behavior (Suicide attempt) was reported in 1 bupropion ... subject ... the event occurred 26 days after study treatment had been stopped'; reported deaths 'included 1 bupropion subject (Overdose)', a heroin overdose. Psychiatric cohort, Table 15: 'bupropion-Suicide attempt plus Schizoaffective disorder'."
    }
   ],
   "note": "The two suicide attempts are in different cohorts, and the overdose was a death during treatment, so the three are different participants. The serious suicidal ideation is not in the briefing's lists, so any serious suicidality is 2 or 3."
  },
  {
   "comparison": "NCT01473381#1",
   "group": "EG002",
   "arm": "antidepressant",
   "title": "Vilazodone 40 mg/day (VLZ-MD-01)",
   "outcomes": {
    "S1": [
     1,
     1
    ],
    "S15": [
     1,
     1
    ],
    "S3": [
     1,
     1
    ]
   },
   "basis": "elimination",
   "sources": [
    {
     "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5540350/",
     "says": "Table 3, the four short-term MDD trials pooled (this one among them), vilazodone: suicide attempt 2, intentional overdose 1; footnote: 'One attempt includes the one patient with intentional overdose (sleeping medication).'"
    },
    {
     "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4314105/",
     "says": "During double-blind treatment, there was one patient in the vilazodone 40 mg/day group who attempted suicide (reported as an SAE; patient discontinued from the study)."
    }
   ],
   "note": "The pooled trials hold one intentional overdose on vilazodone, this group's, and it was part of a suicide attempt."
  },
  {
   "comparison": "NCT01473394#1",
   "group": "EG000",
   "arm": "placebo",
   "title": "Dose-matched placebo (VLZ-MD-03)",
   "outcomes": {
    "S1": [
     1,
     1
    ],
    "S15": [
     1,
     1
    ],
    "S3": [
     1,
     1
    ]
   },
   "basis": "statement",
   "sources": [
    {
     "url": "https://www.psychiatrist.com/jcp/efficacy-safety-vilazodone-major-depressive-disorder/",
     "says": "During the double-blind taper period, serious adverse events were reported in 1 placebo patient (intentional overdose and suicide attempt; considered related to study drug)."
    }
   ],
   "note": "One participant."
  },
  {
   "comparison": "NCT01255787#1",
   "group": "EG003",
   "arm": "antidepressant",
   "title": "Vortioxetine 20 mg (CCT-002)",
   "outcomes": {
    "S3": [
     1,
     1
    ]
   },
   "basis": "statement",
   "sources": [
    {
     "url": "https://www.pmda.go.jp/drugs/2019/P20191010004/400256000_30100AMX00246_K128_2.pdf",
     "says": "治験薬との因果関係が否定できない重篤な有害事象は、LuAA21004 20mg 群の1例でみられた自殺企図及び自殺念慮並びに他の1例でみられた稽留流産であった (suicide attempt and suicidal ideation in one participant of the 20 mg group; section 2.7.6.30)."
    }
   ],
   "note": "One participant."
  },
  {
   "comparison": "NCT03039192#1",
   "group": "EG001",
   "arm": "antidepressant",
   "title": "Esketamine 84 mg plus standard of care (SUI3001)",
   "outcomes": {
    "S3": [
     3,
     3
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://www.g-ba.de/downloads/92-975-4501/2021-02-26_Modul4B_Esketamin.pdf",
     "says": "Tabelle 4-179, serious AEs possibly related to suicidality, treatment phase to day 25: SUI3001 3/113 (esketamine) and 4/112 (placebo); SUI3002 4/114 and 4/113. Anhang 4-G lists the terms: completed suicide, suicidal depression, intentional overdose, self-injury, suicidal behaviour, suicidal ideation, suicide attempt."
    }
   ],
   "note": "Three participants, as many as the terms the registry lists."
  },
  {
   "comparison": "NCT03039192#1",
   "group": "EG000",
   "arm": "placebo",
   "title": "Placebo plus standard of care (SUI3001)",
   "outcomes": {
    "S3": [
     4,
     4
    ],
    "S2": [
     3,
     3
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://www.g-ba.de/downloads/92-975-4501/2021-02-26_Modul4B_Esketamin.pdf",
     "says": "Tabelle 4-179: SUI3001 placebo 4/112."
    }
   ],
   "note": "Four participants, as many as the terms the registry lists, so the three with suicidal depression or ideation are three."
  },
  {
   "comparison": "NCT03097133#1",
   "group": "EG000",
   "arm": "placebo",
   "title": "Placebo plus standard of care (SUI3002)",
   "outcomes": {
    "S3": [
     4,
     4
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://www.g-ba.de/downloads/92-975-4501/2021-02-26_Modul4B_Esketamin.pdf",
     "says": "Tabelle 4-179: SUI3002 placebo 4/113."
    }
   ],
   "note": "Four participants for the five terms the registry lists."
  },
  {
   "comparison": "NCT00849693#1",
   "group": "EG002",
   "arm": "antidepressant",
   "title": "Fluoxetine 20 mg, acute (HMCL)",
   "outcomes": {
    "S3": [
     3,
     3
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://www.fda.gov/media/84726/download",
     "says": "Suicidal thoughts and self-injurious behaviors were experienced by 4 duloxetine-treated subjects, 3 fluoxetine-treated subjects, and 2 placebo-treated subjects. (p. 78; Table 70 lists fluoxetine Intentional Overdose 1 and Suicidal Ideation 2.)"
    }
   ],
   "note": "Three participants."
  },
  {
   "comparison": "NCT00849693#1",
   "group": "EG003",
   "arm": "placebo",
   "title": "Placebo, acute (HMCL)",
   "outcomes": {
    "S1": [
     2,
     2
    ],
    "S3": [
     2,
     2
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://www.fda.gov/media/84726/download",
     "says": "2 placebo-treated subjects with suicidal thoughts and self-injurious behaviors (p. 78); Table 70 lists placebo Homicidal Ideation 1, Self-Injurious Behaviour 1 and Suicide Attempt 1 in 2 subjects with a serious adverse event."
    }
   ],
   "note": "The self-injurious behaviour and the suicide attempt are two participants, unless the review counted homicidal ideation as a suicidal thought."
  },
  {
   "comparison": "NCT01878292#1",
   "group": "EG002",
   "arm": "antidepressant",
   "title": "Vilazodone 30 mg/day (VLZ-MD-21)",
   "outcomes": {
    "S1": [
     1,
     1
    ],
    "S3": [
     2,
     2
    ]
   },
   "basis": "statement",
   "sources": [
    {
     "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6028869/",
     "says": "three patients in the vilazodone 30-mg/day group (intentional overdose with marketed buspirone and suicide attempt in one patient, pilonidal cyst in one patient, and suicidal ideation in one patient)"
    }
   ],
   "note": "The overdose and the attempt are one participant; the ideation is another."
  },
  {
   "comparison": "NCT02709746#1",
   "group": "EG002",
   "arm": "antidepressant",
   "title": "Vortioxetine 20 mg (12710A)",
   "outcomes": {
    "S3": [
     3,
     3
    ]
   },
   "basis": "count",
   "sources": [
    {
     "url": "https://www.lundbeck.com/content/dam/lundbeck-com/masters/global-site/pdf/study-synopses/12710A%20-%20Integrated%20CSR%20-%20Synopsis_Redacted.pdf",
     "says": "For 6 of the 14 patients with suicide-related TEAEs, at least 1 of the TEAEs (suicidal ideation [6 patients] and suicide attempt [1 patient]) was reported as an SAE"
    },
    {
     "url": "https://www.fda.gov/media/146286/download",
     "says": "Table 27: serious suicidal ideation 0, 1, 3 and 2 and serious suicide attempt 0, 0, 1 and 0 (placebo, 10 mg, 20 mg, fluoxetine)."
    }
   ],
   "note": "All six participants with a serious suicide-related event had suicidal ideation, so the one with the attempt is among this group's three."
  }
 ],
 "unresolved": [
  {
   "comparison": "NCT00602355#1",
   "group": "EG001",
   "outcome": "S3",
   "why": "The trial's report is not openly available, and a Cochrane review says its serious events cannot be assigned to arms."
  },
  {
   "comparison": "NCT00798707#1",
   "group": "EG002",
   "outcome": "S3",
   "why": "No public report gives the events by participant."
  },
  {
   "comparison": "NCT01432457#1",
   "group": "EG001",
   "outcome": "S3",
   "why": "No public report gives the events by participant."
  }
 ]
}