An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR).

1. Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved.
2. Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•BMI (height [only prior to the start of Lipacreon treatment] and weight)

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Serum total protein

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Albumin

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Total cholesterol

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Triglycerides

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Haemoglobin

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Steatorrhoea (Yes/No)

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Frequency of bowel movements (times/day)

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Diarrhoea (Yes/No)

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Foul stool odour (Yes/No)

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Inappetence (Yes/No)

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.

•Abdominal distension (Yes/No)

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients.

Degree of general improvement was assessed at 24 weeks after the start of Lipacreon treatment and at the completion of the 52-week observation period, using the following 4 grades:

Improved, unchanged, exacerbated, unassessable

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients. Of these 21 patients, 17 patients were obtained with data on Degree of General Improvement at 24 weeks.

Degree of general improvement was assessed at 24 weeks after the start of Lipacreon treatment and at the completion of the 52-week observation period, using the following 4 grades:

Improved, unchanged, exacerbated, unassessable

Among the 21 patients from whom the survey forms were collected, no patient was excluded from the safety analysis or efficacy analysis, and both the safety analysis set and the efficacy analysis set included 21 patients. Of these 21 patients, 14 patients were obtained with data on Degree of General Improvement at 52 weeks.