Table 1.
Enhanced Individual Case Line Listing provided from Eudra Vigilance Data Analysis System (EVDAS), adapted.
| Country | Receive Date | Age, Sex | Primary Source Qualification | Serious | Death | Hosp. | Literature Reference | Indication | Concomitant Drugs | Reaction List/Outcome/Medical History |
|---|---|---|---|---|---|---|---|---|---|---|
| USA | 10 December 2008 | NS | Healthcare pro | No | No | No | No | No | No reported | intentional misuse/somnolence/ NA |
| UK | 03 Janauary 2013 | 28 male | Healthcare pro | Yes | No | Yes | No | No | methadone | drug abuse/syncope, recovered/NA |
| UK | 26 July 2013 | 31 male | Healthcare pro | Yes | No | No | No | No | methadone, DZP | drug dependence/unknown/NA |
| Den | 23 February 2012 | 20 male | Healthcare pro | Yes | No | Yes | No | GAD | ZLP, Que, Xep | drug abuse/seizure, limb injury, not recovered/schizophrenia |
| Japan | 22 August 2014 | 63 male | Healthcare pro | Yes | Yes | No | No | neuralgia | nedaplatin, FRS, PCT | drug-induced liver injury/intentional misuse/death/oesophageal carcinoma/DM-II |
| UK | 29 October 2014 | NS male | Healthcare pro | Yes | Yes | No | No | No | No reported | death/NA |
| Ger | 11 September 2014 | 42 male | Healthcare pro | Yes | No | Yes | No | No | No reported | drug dependence/withdrawal/unknown/hepatitis C/drug dependence |
| France | 29 November 2016 | 35 male | Healthcare pro | Yes | No | Yes | No | No | clonazepam, PCT | intentional product misuse/recovered/Asthma/drug dependence |
| France | 13 December 2016 | 35 male | Healthcare pro | Yes | No | Yes | No | No | No reported | conduction disorder/drug dependence/unknown/drug dependence/subutex |
| UK | 23 June 2017 | 27 male | Non-Healthcare pro | Yes | No | No | No | anxiety | No reported | anxiety/intentional misuse/condition aggravated/NA |
| Ger | 08 November 2017 | NS | Healthcare pro | Yes | No | No | No | No | No reported | drug abuse/unknown/NA |
| Ger | 18 January 2018 | 27 male | Healthcare pro | No | NA | NA | Snellgrove et al. | No | No reported | drug abuse/unknown/NA |
| Austria | 25 January 2018 | NS male | Non-Healthcare pro | Yes | No | No | No | No | No reported | drug abuse/euphoric mood/unknown/ drug withdrawal maintenance |
NS = not specified; AA = not available; SAR = severe adverse reaction; Hosp. = Hospitalization; GAD = generalized anxiety disorder; DM = diabetes mellitus; DZP = Diazepam; PCT = Paracetamol; ZLP =Zolpidem; Que = Quetiapine; Xep = Xeplion (Paliperidone Palmitate); FRS = Furosemide; PCT = Paclitaxel; NA = non-applicable; Ger = Germany; Den = Denmark.