Trial Outcomes & Findings for Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs (NCT NCT02099708)

NCT ID: NCT02099708

Last Updated: 2016-10-27

Results Overview

Frequency was defined as the number of participants for each adverse event Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

• Recruitment status: COMPLETED
• Target enrollment: 3502 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-10-27

Participant Flow

Participants took part in the study at 501 investigative sites in Japan from October 2010 to March 2014 (N=3,502).

Patients with a history of gastric or duodenal ulcers and requiring long-term use of nonsteroidal anti-inflammatory drugs were enrolled in the study.

Participant milestones

Measure	Lansoprazole 15 mg Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Overall Study STARTED	3502
Overall Study Safety Analysis Set (SAS)	3302
Overall Study COMPLETED	3302
Overall Study NOT COMPLETED	200

Reasons for withdrawal

Measure	Lansoprazole 15 mg Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Overall Study Data Not Available	30
Overall Study Lost to Follow-up	141
Overall Study Other	29

Baseline Characteristics

Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

Baseline characteristics by cohort

Measure	Lansoprazole 15 mg n=3302 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Age, Continuous	67.9 years STANDARD_DEVIATION 14.21 • n=5 Participants
Sex: Female, Male Female	2268 Participants n=5 Participants
Sex: Female, Male Male	1034 Participants n=5 Participants
Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment Rheumatoid arthritis	573 participants n=5 Participants
Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment Osteoarthritis	1729 participants n=5 Participants
Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment Other	1116 participants n=5 Participants
Details of the History of Gastric or Duodenal Ulcers: Site of Disease Gastric ulcer	2632 participants n=5 Participants
Details of the History of Gastric or Duodenal Ulcers: Site of Disease Gastroduodenal ulcer	207 participants n=5 Participants
Details of the History of Gastric or Duodenal Ulcers: Site of Disease Unknown	490 participants n=5 Participants
Details of the History of Gastric or Duodenal Ulcers: Time of Emergence <6 months before treatment	161 participants n=5 Participants
Details of the History of Gastric or Duodenal Ulcers: Time of Emergence ≥ 6 months to < 1 year before treatment	63 participants n=5 Participants
Details of the History of Gastric or Duodenal Ulcers: Time of Emergence ≥ 1 year before treatment	449 participants n=5 Participants
Details of the History of Gastric or Duodenal Ulcers: Time of Emergence Unknown	2629 participants n=5 Participants
Presence or Absence of H. Pylori Infection Negative	276 participants n=5 Participants
Presence or Absence of H. Pylori Infection Positive	55 participants n=5 Participants
Presence or Absence of H. Pylori Infection Unknown	2971 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety analysis set (SAS) - All participants who received at least 1 dose of open-label study drug.

Frequency was defined as the number of participants for each adverse event Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

Outcome measures

Measure	Lansoprazole 15 mg n=3302 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Frequency of Adverse Drug Reactions Bronchitis	1 participants
Frequency of Adverse Drug Reactions Colon cancer	1 participants
Frequency of Adverse Drug Reactions Depression	1 participants
Frequency of Adverse Drug Reactions Cervical radiculopathy	1 participants
Frequency of Adverse Drug Reactions Atrial fibrillation	1 participants
Frequency of Adverse Drug Reactions Cardiac failure	1 participants
Frequency of Adverse Drug Reactions Myocardial ischaemia	1 participants
Frequency of Adverse Drug Reactions Abdominal discomfort	4 participants
Frequency of Adverse Drug Reactions Abdominal pain upper	1 participants
Frequency of Adverse Drug Reactions Colitis	1 participants
Frequency of Adverse Drug Reactions Constipation	2 participants
Frequency of Adverse Drug Reactions Diarrhoea	8 participants
Frequency of Adverse Drug Reactions Enterocolitis	1 participants
Frequency of Adverse Drug Reactions Nausea	1 participants
Frequency of Adverse Drug Reactions Oral mucosal blistering	1 participants
Frequency of Adverse Drug Reactions Stomatitis	1 participants
Frequency of Adverse Drug Reactions Colitis microscopic	1 participants
Frequency of Adverse Drug Reactions Faeces soft	2 participants
Frequency of Adverse Drug Reactions Eczema	1 participants
Frequency of Adverse Drug Reactions Hyperhidrosis	1 participants
Frequency of Adverse Drug Reactions Rash	1 participants
Frequency of Adverse Drug Reactions Generalised erythema	1 participants
Frequency of Adverse Drug Reactions Osteoporosis	2 participants
Frequency of Adverse Drug Reactions Feeling abnormal	1 participants
Frequency of Adverse Drug Reactions Thirst	2 participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.

Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.

Outcome measures

Measure	Lansoprazole 15 mg n=3248 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Presence or Absence of Endoscopic Examinations No	3098 participants
Presence or Absence of Endoscopic Examinations Yes	150 participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.

Summary of data on the presence or absence of gastric or duodenal ulcer.

Outcome measures

Measure	Lansoprazole 15 mg n=3248 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Presence of Gastric or Duodenal Ulcer No	3239 Participants
Presence of Gastric or Duodenal Ulcer Yes	9 Participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.

Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.

Outcome measures

Measure	Lansoprazole 15 mg n=3248 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion No	3244 participants
Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion Yes	4 participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.

Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.

Outcome measures

Measure	Lansoprazole 15 mg n=3248 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion No	3237 participants
Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion Yes	11 participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.

Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.

Outcome measures

Measure	Lansoprazole 15 mg n=3248 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Treatment for Gastric/Duodenal Ulcer or Lesion No	0 participants
Treatment for Gastric/Duodenal Ulcer or Lesion Yes	11 participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.

Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.

Participants could be counted in more than 1 treatment category.

Outcome measures

Measure	Lansoprazole 15 mg n=3248 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Takepron Capsule or OD Tablets 15 mg	4 participants
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Takepron Capsule or OD Tablet 30 mg	1 participants
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Rabeprazole tablet 10 mg	1 participants
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Rabeprazole tablet 20 mg	1 participants
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions H2 receptor antagonist (oral)	1 participants
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Other peptic ulcer medication	4 participants
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Endoscopic hemostasis	1 participants
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Other	4 participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.

Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.

Outcome measures

Measure	Lansoprazole 15 mg n=3248 Participants Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Takepron 15 mg - Resolving	3 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Takepron 15 mg - Unknown	1 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Takepron 30 mg - Resolved	1 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Rabeprazole 10 mg _Resolved	1 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Rabeprazole 20 mg - Resolved	1 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions H2 receptor antagonist - Resolved	1 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Other peptic ulcer medication - Resolved	3 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Other peptic ulcer medication - Resolving	1 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Endoscopic hemostasis - Resolving	1 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Other - Resolved	1 participants
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions Other - Resolving	3 participants

Adverse Events

Lansoprazole 15 mg

Serious events: 50 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lansoprazole 15 mg n=3302 participants at risk Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Infections and infestations Cellulitis	0.06% 2/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Infections and infestations Meningitis bacterial	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Infections and infestations Pneumonia	0.06% 2/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Infections and infestations Sepsis	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Infections and infestations Infectious pleural effusion	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.09% 3/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.24% 8/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.06% 2/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucinous adenocarcinoma of appendix	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Psychiatric disorders Delirium	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Nervous system disorders Cerebral artery embolism	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Nervous system disorders Cerebral infarction	0.06% 2/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Nervous system disorders Cervical myelopathy	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Nervous system disorders Coma	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Nervous system disorders Transient ischaemic attack	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Cardiac disorders Atrial fibrillation	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Cardiac disorders Cardiac failure	0.09% 3/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Cardiac disorders Cardiac failure congestive	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Cardiac disorders Myocardial infarction	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Cardiac disorders Myocardial ischaemia	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.06% 2/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Gastrointestinal disorders Gastrointestinal perforation	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Gastrointestinal disorders Ileus	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Gastrointestinal disorders Melaena	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.06% 2/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Musculoskeletal and connective tissue disorders Osteoporosis	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Renal and urinary disorders Renal failure acute	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Renal and urinary disorders Bladder tamponade	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
General disorders Malaise	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
General disorders General physical health deterioration	0.06% 2/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Injury, poisoning and procedural complications Fall	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Injury, poisoning and procedural complications Femoral neck fracture	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Injury, poisoning and procedural complications Femur fracture	0.06% 2/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Surgical and medical procedures Nephrectomy	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Surgical and medical procedures Incisional drainage	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Surgical and medical procedures Spinal operation	0.03% 1/3302 • 12 months Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

Other adverse events

Adverse event data not reported

Additional Information

Medical Director, Clinical Science

Takeda

Phone: 800-778-2860

Email: clinicaltrialregistry@tpna.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER