Table 1.

Examples of inclusion and exclusion criteria for cases of adverse drug reactions in published studies.

	Inclusion criteria	Exclusion criteria
Agranulocytosis [18, 19]	(1) An absolute neutrophil count of 0.5 × 109/L (≤500/μL) or less during non-chemotherapy drug treatment or within 7 days of stopping treatment; (2) Complete recovery after cessation of the drug, with an absolute neutrophil count of more than 1.0 × 109/L (>1000/μL) or a compatible bone marrow aspirate or biopsy finding.	(1) Anticancer chemotherapy within 1 month of onset of agranulocytosis; (2) Radiation therapy within the previous month; (3) Bone marrow transplantation at any time; (4) Ongoing infection with Epstein-Barr virus, hepatitis A virus, HIV, cytomegalovirus, or parvovirus B19; (5) Ongoing sepsis; (6) Ongoing miliary tuberculosis; (7) Current presence of chronic neutropenia (congenital cyclic or idiopathic); (8) Ongoing immunosuppressive therapy with cytotoxic drugs; (9) Current presence of malignant infiltration of bone marrow; (10) Hematological diseases (eg, myelodysplasia, aplastic anemia, pancytopenia, and other blood dyscrasias, such as hemoglobin ≤100 g/L or platelets ≤100 × 109/L); (11) Current presence of systemic lupus erythematosus.
Angioedema due to ACE-inhibitors and ARBs [41]	(1) Symptoms in the head and neck region judged to be angioedema by a physician; (2) The initial event should occur during treatment with an ACE inhibitor or ARB; (3) It may recur after cessation of treatment.	1) Symptoms coinciding with urticaria; 2) Another likely cause such as severe facial trauma or infection; 3) Association with C1 inhibitor or complement deficiency (if this data is available); 4) Mutation in the C1 inhibitor (SERPING1) or factor XII (F12) gene (if this data is available).
Atypical femoral fractures due to bisphosphonates [22]	(1) The event should occur during or after bisphosphonate treatment; (2) The fracture must be located along the femoral diaphysis from just distal to the lesser trochanter to just proximal to the supracondylar flare; (3) At least four of the following features (a–e) must be present: (a) The fracture is associated with minimal or no trauma, as in a fall from a standing height or less; (b) The fracture line originates at the lateral cortex and is substantially transverse in its orientation, although it may become oblique as it progresses medially across the femur; (c) Complete fractures extend through both cortices and may be associated with a medial spike; incomplete fractures involve only the lateral cortex; (d) The fracture is noncomminuted or minimally comminuted; (e) Localized periosteal or endosteal thickening of the lateral cortex is present at the fracture site (“beaking” or “flaring”).	1) Fractures of the femoral neck, intertrochanteric fractures with spiral subtrochanteric extension, periprosthetic fractures, and pathological fractures associated with primary or metastatic bone tumors and miscellaneous bone diseases (eg, Paget’s disease, fibrous dysplasia).
Narcolepsy due to swine influenza A (H1N1) vaccination (Pandemrix) [21]	(1) Onset of symptoms after Pandemrix vaccination. Narolepsy type 1: (1) The patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least three months; (2) The presence of one or both of the following (a-b): (a) Cataplexy and a mean sleep latency of ≤8 min and two or more sleep onset REM periods (SOREMPs) on a multiple sleep latency test (MSLT) performed according to standard techniques. A SOREMP (within 15 minutes of sleep onset) on the preceding nocturnal polysomnogram may replace one of the SOREMPs on the MSLT; (b) Cerebrospinal fluid (CSF) hypocretin-1 concentration, measured by immunoreactivity, is either ≤110 pg/mL or <1/3 of mean values obtained in normal subjects with the same standardized assay. Narcolepsy type 2: (1) The patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least three months; (2) A mean sleep latency of ≤8 min and two or more SOREMPs are found on a MSLT performed according to standard techniques. A SOREMP (within 15 minutes of sleep onset) on the preceding nocturnal polysomnogram may replace one of the SOREMPs on the MSLT; (3) Cataplexy is absent; (4) Either CSF hypocretin-1 concentration has not been measured or CSF hypocretin-1 concentration measured by immunoreactivity is either >110 pg/mL or >1/3 of mean values obtained in normal subjects with the same standardized assay; (5) The hypersomnolence and/or MSLT findings are not better explained by other causes such as insufficient sleep, obstructive sleep apnea, delayed sleep phase disorder, or the effect of medication or substances or their withdrawal.	1) Onset of symptoms prior to Pandemrix vaccination.

ACE angiotensin-converting enzyme, ARB angiotensin II receptor type 1 blocker