Trial Outcomes & Findings for Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency (NCT NCT01427725)

Last Updated: 2022-06-13

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

579 participants

Primary outcome timeframe

At week 52

Results posted on

2022-06-13

Participant Flow

From August 30, 2011 to July 31, 2014, 579 patients were registered at 144 departments of 136 facilities (patient registration period: August 30, 2011 to July 31, 2014) and the survey forms of 562 patients were collected from 140 departments of 132 facilities.

For this survey, the contract for the conduct of the survey was concluded with 190 departments of 181 facilities during the period from August 30, 2011 to July 31, 2014.

Participant milestones

Participant milestones
Measure	LipaCreon those with an exposure
Overall Study STARTED	579
Overall Study Collected CRFs	562
Overall Study Safety Analysis Set	553
Overall Study COMPLETED	378
Overall Study NOT COMPLETED	201

Reasons for withdrawal

Reasons for withdrawal
Measure	LipaCreon those with an exposure
Overall Study Lost to Follow-up	17
Overall Study Protocol Violation	1
Overall Study Drug not administered	1
Overall Study Failure to visit	7
Overall Study Adverse Event	46
Overall Study Failure to visit after administration	40
Overall Study Patient's rejection	27
Overall Study Transfer to a different hospital	17
Overall Study Lack of Efficacy	8
Overall Study Death	7
Overall Study Symptom improvement	6
Overall Study AE and Patient's rejection	5
Overall Study Physician Decision	5
Overall Study Exacerbation of underlying disease	5
Overall Study Oral feeding difficulty	5
Overall Study Lack of Efficacy and Patient's rejection	1
Overall Study Forgetting prescription	1
Overall Study Other	2

Baseline Characteristics

Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LipaCreon n=553 Participants those with an exposure
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	243 Participants n=5 Participants
Age, Categorical >=65 years	310 Participants n=5 Participants
Age, Continuous	65.2 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	210 Participants n=5 Participants
Sex: Female, Male Male	343 Participants n=5 Participants
Region of Enrollment Japan	553 participants n=5 Participants

PRIMARY outcome

Timeframe: At week 52

Outcome measures

Outcome measures
Measure	LipaCreon n=553 Participants those with an exposure
Number of Patients With Adverse Drug Reaction	36 participants

SECONDARY outcome

Timeframe: At week 24

Population: Among patients in the safety analysis set, 547 patients were included in the efficacy analysis set, excluding 6 patients who were excluded from the efficacy analysis set (Reasons: Unassessable: 5 patients; and off-label use: 1 patient). Among patients in the 547 patients, the patients for which data were obtained at each time frame were analyzed.

It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable

Outcome measures

Outcome measures
Measure	LipaCreon n=404 Participants those with an exposure
Degree of General Improvement Improved	299 Participants
Degree of General Improvement Unchanged	87 Participants
Degree of General Improvement Exacerbated	3 Participants
Degree of General Improvement Unassessable	15 Participants

SECONDARY outcome

Timeframe: At week 52

It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable

Outcome measures

Outcome measures
Measure	LipaCreon n=314 Participants those with an exposure
Degree of General Improvement Improved	240 Participants
Degree of General Improvement Unchanged	62 Participants
Degree of General Improvement Exacerbated	1 Participants
Degree of General Improvement Unassessable	11 Participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Nutritional Endpoints - BMI Baseline	20.452 kg/m2 Standard Deviation 3.144
Nutritional Endpoints - BMI 4 weeks	20.193 kg/m2 Standard Deviation 2.933
Nutritional Endpoints - BMI 8 weeks	20.229 kg/m2 Standard Deviation 2.991
Nutritional Endpoints - BMI 24 weeks	20.520 kg/m2 Standard Deviation 2.847
Nutritional Endpoints - BMI 52 weeks	20.720 kg/m2 Standard Deviation 2.853

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Nutritional Endpoints - Serum Total Protein Baseline	6.579 g/dL Standard Deviation 0.798
Nutritional Endpoints - Serum Total Protein 4 weeks	6.955 g/dL Standard Deviation 3.500
Nutritional Endpoints - Serum Total Protein 8 weeks	6.761 g/dL Standard Deviation 0.654
Nutritional Endpoints - Serum Total Protein 24 weeks	6.901 g/dL Standard Deviation 0.596
Nutritional Endpoints - Serum Total Protein 52 weeks	6.914 g/dL Standard Deviation 0.637

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Nutrition Endpoints - Albumin 8 weeks	3.843 g/dL Standard Deviation 0.628
Nutrition Endpoints - Albumin Baseline	3.688 g/dL Standard Deviation 0.663
Nutrition Endpoints - Albumin 4 weeks	3.912 g/dL Standard Deviation 2.164
Nutrition Endpoints - Albumin 24 weeks	3.984 g/dL Standard Deviation 0.509
Nutrition Endpoints - Albumin 52 weeks	3.959 g/dL Standard Deviation 0.579

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Nutrition Endpoints - Total Cholesterol Baseline	164.32 mg/dL Standard Deviation 47.63
Nutrition Endpoints - Total Cholesterol 4 weeks	169.40 mg/dL Standard Deviation 45.34
Nutrition Endpoints - Total Cholesterol 8 weeks	169.77 mg/dL Standard Deviation 45.99
Nutrition Endpoints - Total Cholesterol 24 weeks	168.88 mg/dL Standard Deviation 39.90
Nutrition Endpoints - Total Cholesterol 52 weeks	169.41 mg/dL Standard Deviation 38.27

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. PCS8 score is calculated by the following formula (All summed). PCS8 score = (0.23024×SF8GH)+(0.40672×SF8PF)+(0.38317×SF8RP)+(0.33295×SF8BP)+(0.07537×SF8VT)+(-0.01275×SF8SF)+(-0.30469×SF8MH)+(-0.14803×SF8RE)+0.67371 The minimum value of PCS8 is 5.315, and the maximum value is 70.689. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Physical Health (Summary) Baseline	42.057 score on a scale Standard Deviation 9.590
Patient's Quality of Life - Physical Health (Summary) 8 weeks	46.086 score on a scale Standard Deviation 7.750
Patient's Quality of Life - Physical Health (Summary) 24 weeks	47.919 score on a scale Standard Deviation 7.414
Patient's Quality of Life - Physical Health (Summary) 52 weeks	48.985 score on a scale Standard Deviation 7.109

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea Baseline, Yes	84 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea Baseline, No	386 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea 4 weeks, Yes	33 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea 4 weeks, No	330 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea 8 weeks, Yes	22 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea 8 weeks, No	333 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea 24 weeks, Yes	15 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea 24 weeks, No	332 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea 52 weeks, Yes	6 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea 52 weeks, No	270 participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Nutrition Endpoints - Triglycerides Baseline	123.5 mg/dL Standard Deviation 115.0
Nutrition Endpoints - Triglycerides 4 weeks	128.8 mg/dL Standard Deviation 95.4
Nutrition Endpoints - Triglycerides 8 weeks	118.6 mg/dL Standard Deviation 90.1
Nutrition Endpoints - Triglycerides 24 weeks	117.9 mg/dL Standard Deviation 70.6
Nutrition Endpoints - Triglycerides 52 weeks	126.5 mg/dL Standard Deviation 103.5

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Nutrition Endpoints - Haemoglobin 8 weeks	12.12 g/dL Standard Deviation 1.95
Nutrition Endpoints - Haemoglobin Baseline	12.18 g/dL Standard Deviation 1.99
Nutrition Endpoints - Haemoglobin 4 weeks	12.03 g/dL Standard Deviation 1.84
Nutrition Endpoints - Haemoglobin 24 weeks	12.40 g/dL Standard Deviation 1.96
Nutrition Endpoints - Haemoglobin 52 weeks	12.58 g/dL Standard Deviation 1.88

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. MCS8 score is calculated by the following formula (All summed). MCS8 score = (-0.02020×SF8GH)+(-0.19972×SF8PF)+(-0.16579×SF8RP)+(-0.15992×SF8BP)+(0.16737×SF8VT)+(0.27264×SF8SF)+(0.57583×SF8MH)+(0.42927×SF8RE)+4.34744 The minimum value of MCS8 is 10.108, and the maximum value is 74.511. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Mental Health (Summary) Baseline	44.619 score on a scale Standard Deviation 8.405
Patient's Quality of Life - Mental Health (Summary) 8 weeks	47.864 score on a scale Standard Deviation 7.255
Patient's Quality of Life - Mental Health (Summary) 24 weeks	49.288 score on a scale Standard Deviation 6.230
Patient's Quality of Life - Mental Health (Summary) 52 weeks	49.894 score on a scale Standard Deviation 6.308

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8GH scores; 1:63.38, 2:58.54, 3:50.27, 4:40.40, 5:34.38, 6:26.89 The minimum value of SF8GH is 26.89, and the maximum value is 63.38. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - General Health Baseline	43.673 score on a scale Standard Deviation 8.513
Patient's Quality of Life - General Health 8 weeks	48.238 score on a scale Standard Deviation 7.395
Patient's Quality of Life - General Health 24 weeks	50.250 score on a scale Standard Deviation 7.306
Patient's Quality of Life - General Health 52 weeks	51.479 score on a scale Standard Deviation 7.030

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8PF scores; 1:53.54, 2:47.77, 3:41.45, 4:27.59, 5:16.69 The minimum value of SF8PF is 16.69, and the maximum value is 53.54. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Physical Functioning 24 weeks	47.438 score on a scale Standard Deviation 7.617
Patient's Quality of Life - Physical Functioning 52 weeks	48.325 score on a scale Standard Deviation 7.166
Patient's Quality of Life - Physical Functioning Baseline	41.941 score on a scale Standard Deviation 10.463
Patient's Quality of Life - Physical Functioning 8 weeks	45.630 score on a scale Standard Deviation 8.628

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8RP scores; 1:54.09, 2:47.42, 3:40.65, 4:27.91, 5:21.80. The minimum value of SF8RP is 21.80, and the maximum value is 54.09. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Role Physical Baseline	41.325 score on a scale Standard Deviation 10.707
Patient's Quality of Life - Role Physical 8 weeks	45.253 score on a scale Standard Deviation 8.983
Patient's Quality of Life - Role Physical 24 weeks	47.371 score on a scale Standard Deviation 8.034
Patient's Quality of Life - Role Physical 52 weeks	48.222 score on a scale Standard Deviation 7.553

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8BP scores; 1:60.35, 2:52.46, 3:46.10, 4:38.21, 5:31.59, 6:21.68. The minimum value of SF8BP is 21.68, and the maximum value is 60.35. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Body Pain Baseline	48.282 score on a scale Standard Deviation 10.178
Patient's Quality of Life - Body Pain 8 weeks	52.407 score on a scale Standard Deviation 8.162
Patient's Quality of Life - Body Pain 24 weeks	53.746 score on a scale Standard Deviation 7.906
Patient's Quality of Life - Body Pain 52 weeks	54.594 score on a scale Standard Deviation 7.852

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8VT scores; 1:60.01, 2:53.74, 3:44.48, 4:38.51, 5:28.68. The minimum value of SF8VT is 28.68, and the maximum value is 60.01. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Vitality Baseline	44.425 score on a scale Standard Deviation 8.216
Patient's Quality of Life - Vitality 8 weeks	48.408 score on a scale Standard Deviation 7.718
Patient's Quality of Life - Vitality 24 weeks	50.263 score on a scale Standard Deviation 7.183
Patient's Quality of Life - Vitality 52 weeks	51.463 score on a scale Standard Deviation 6.919

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8SF scores; 1:55.14, 2:45.60, 3:37.65, 4:29.15, 5:26.00. The minimum value of SF8SF is 26.00, and the maximum value is 55.14. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Social Functioning Baseline	42.345 score on a scale Standard Deviation 10.332
Patient's Quality of Life - Social Functioning 8 weeks	46.073 score on a scale Standard Deviation 9.255
Patient's Quality of Life - Social Functioning 24 weeks	47.749 score on a scale Standard Deviation 8.393
Patient's Quality of Life - Social Functioning 52 weeks	48.633 score on a scale Standard Deviation 7.973

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8MH scores; 1:56.93, 2:50.72, 3:44.94, 4:36.30, 5:27.59. The minimum value of SF8MH is 27.59, and the maximum value is 56.93. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Mental Health Baseline	46.066 score on a scale Standard Deviation 8.459
Patient's Quality of Life - Mental Health 8 weeks	49.619 score on a scale Standard Deviation 7.245
Patient's Quality of Life - Mental Health 24 weeks	51.326 score on a scale Standard Deviation 6.267
Patient's Quality of Life - Mental Health 52 weeks	51.745 score on a scale Standard Deviation 6.395

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks, and 52 weeks

Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8RE scores; 1:54.19, 2:48.04, 3:42.24, 4:31.42, 5:19.98. The minimum value of SF8RE is 19.98, and the maximum value is 54.19. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Patient's Quality of Life - Role Emotional Baseline	43.320 score on a scale Standard Deviation 9.704
Patient's Quality of Life - Role Emotional 8 weeks	47.179 score on a scale Standard Deviation 7.930
Patient's Quality of Life - Role Emotional 24 weeks	48.670 score on a scale Standard Deviation 6.778
Patient's Quality of Life - Role Emotional 52 weeks	49.607 score on a scale Standard Deviation 6.561

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements Baseline	2.37 times/day Standard Deviation 1.87
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements 4 weeks	1.82 times/day Standard Deviation 1.33
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements 8 weeks	1.77 times/day Standard Deviation 1.42
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements 24 weeks	1.51 times/day Standard Deviation 0.96
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements 52 weeks	1.43 times/day Standard Deviation 0.81

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea Baseline, Yes	187 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea Baseline, No	296 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea 4 weeks, Yes	81 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea 4 weeks, No	295 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea 8 weeks, Yes	72 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea 8 weeks, No	293 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea 24 weeks, Yes	45 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea 24 weeks, No	313 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea 52 weeks, Yes	29 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea 52 weeks, No	256 participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour Baseline, Yes	83 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour Baseline, No	377 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour 4 weeks, Yes	37 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour 4 weeks, No	323 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour 8 weeks, Yes	30 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour 8 weeks, No	320 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour 24 weeks, Yes	21 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour 24 weeks, No	323 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour 52 weeks, Yes	18 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour 52 weeks, No	256 participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite Baseline, Yes	169 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite Baseline, No	313 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite 4 weeks, Yes	72 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite 4 weeks, No	304 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite 8 weeks, Yes	58 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite 8 weeks, No	304 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite 24 weeks, Yes	37 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite 24 weeks, No	318 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite 52 weeks, Yes	17 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite 52 weeks, No	266 participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Outcome measures

Outcome measures
Measure	LipaCreon n=547 Participants those with an exposure
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension Baseline, Yes	130 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension Baseline, No	345 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension 4 weeks, Yes	42 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension 4 weeks, No	330 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension 8 weeks, Yes	37 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension 8 weeks, No	322 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension 24 weeks, Yes	27 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension 24 weeks, No	324 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension 52 weeks, Yes	12 participants
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension 52 weeks, No	268 participants

Adverse Events

LipaCreon

Serious events: 81 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LipaCreon n=553 participants at risk those with an exposure
Infections and infestations Endocarditis	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Infections and infestations Pneumonia	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Infections and infestations Sepsis	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Infections and infestations Urinary tract infection	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Infections and infestations Abdominal abscess	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.54% 3/553 • Number of events 3 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer recurrent	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer recurrent	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.72% 4/553 • Number of events 4 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	3.1% 17/553 • Number of events 17 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma recurrent	0.90% 5/553 • Number of events 5 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Recurrent cancer	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.72% 4/553 • Number of events 4 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour invasion	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix cancer	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Blood and lymphatic system disorders Anaemia	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Blood and lymphatic system disorders Febrile neutropenia	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Metabolism and nutrition disorders Hyperglycaemia	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Metabolism and nutrition disorders Hypoalbuminaemia	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Metabolism and nutrition disorders Hypocholesterolaemia	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Metabolism and nutrition disorders Hypoproteinaemia	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Metabolism and nutrition disorders Decreased appetite	1.1% 6/553 • Number of events 6 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Nervous system disorders Cerebral infarction	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Nervous system disorders Hypogeusia	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Cardiac disorders Acute myocardial infarction	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Cardiac disorders Cardiac failure	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Cardiac disorders Cardiac failure congestive	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Cardiac disorders Coronary artery disease	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Abdominal distension	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Abdominal pain	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Ascites	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Colitis ischaemic	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Diarrhoea	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Gastric ulcer	0.54% 3/553 • Number of events 3 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Ileus	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Intestinal obstruction	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Mesenteric artery embolism	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Pancreatitis	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Pancreatitis acute	0.36% 2/553 • Number of events 3 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Small intestine ulcer	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Stomatitis	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Vomiting	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Duodenal stenosis	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Pancreatic duct stenosis	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Gastrointestinal disorders Autoimmune pancreatitis	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Hepatobiliary disorders Bile duct stone	0.18% 1/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Hepatobiliary disorders Cholangitis	0.54% 3/553 • Number of events 5 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Hepatobiliary disorders Cholangitis acute	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Hepatobiliary disorders Hepatic failure	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Hepatobiliary disorders Jaundice cholestatic	0.54% 3/553 • Number of events 3 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Hepatobiliary disorders Drug-induced liver injury	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Skin and subcutaneous tissue disorders Eczema asteatotic	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Musculoskeletal and connective tissue disorders Back pain	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Skin and subcutaneous tissue disorders Intervertebral disc protrusion	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Renal and urinary disorders Chronic kidney disease	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
General disorders Malaise	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
General disorders Oedema	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
General disorders Oedema peripheral	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Investigations Blood albumin decreased	0.36% 2/553 • Number of events 2 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Investigations Low density lipoprotein increased	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Investigations Protein total decreased	0.54% 3/553 • Number of events 3 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Investigations Weight decreased	0.54% 3/553 • Number of events 3 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Investigations Weight increased	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Investigations White blood cell count decreased	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Injury, poisoning and procedural complications Alcohol poisoning	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Injury, poisoning and procedural complications Femoral neck fracture	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Injury, poisoning and procedural complications Femur fracture	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Injury, poisoning and procedural complications Spinal compression fracture	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Injury, poisoning and procedural complications Subdural haematoma	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Injury, poisoning and procedural complications Chemical peritonitis	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).
Social circumstances Activities of daily living impaired	0.18% 1/553 • Number of events 1 • From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).

Other adverse events

Adverse event data not reported

Additional Information

Medical affairs manager

Medical affairs

Phone: +81-3-5656-0516

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place