Trial Outcomes & Findings for Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study) (NCT NCT01398410)
NCT ID: NCT01398410
Last Updated: 2015-12-21
Results Overview
An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
405 participants
Primary outcome timeframe
For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)
Results posted on
2015-12-21
Participant Flow
From a total of 420 participants who completed the E3810-J081-308 (NCT01397448) study, 405 entered the E3810-J081-309 (NCT01398410) study.
Participant milestones
| Measure |
Rabeprazole 5 mg
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
|
Rabeprazole 10 mg
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
204
|
|
Overall Study
COMPLETED
|
143
|
148
|
|
Overall Study
NOT COMPLETED
|
58
|
56
|
Reasons for withdrawal
| Measure |
Rabeprazole 5 mg
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
|
Rabeprazole 10 mg
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
16
|
|
Overall Study
Participants Choice
|
8
|
11
|
|
Overall Study
Inadequate Therapeutic Effect
|
2
|
0
|
|
Overall Study
Other
|
36
|
29
|
Baseline Characteristics
Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Baseline characteristics by cohort
| Measure |
Rabeprazole 5 mg
n=201 Participants
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
|
Rabeprazole 10 mg
n=204 Participants
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
70.1 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
69.8 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)Population: The analysis was performed using Safety Analysis Set, defined as all participants who received at least one dose of rabeprazole.
An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.
Outcome measures
| Measure |
Rabeprazole 5 mg
n=201 Participants
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
|
Rabeprazole 10 mg
n=204 Participants
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs)
|
77.1 Percentage of participants
|
83.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)Population: The analysis was performed using Full Analysis Set, defined as all participants who received at least one dose of rabeprazole, with at least one post-initiation endoscopic assessment results, and showed no ulcers on baseline endoscopy; excluding participants from the newly-initiated rabeprazole groups of study E3810-J081-309.
Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers.
Outcome measures
| Measure |
Rabeprazole 5 mg
n=150 Participants
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
|
Rabeprazole 10 mg
n=151 Participants
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
|
|---|---|---|
|
Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
Baseline (N=150, 151)
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
Week 12 (N=150, 151)
|
1.3 Percentage of participants
Interval 0.34 to 5.23
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
Week 24 (N=139, 142)
|
2.8 Percentage of participants
Interval 1.04 to 7.17
|
1.4 Percentage of participants
Interval 0.35 to 5.51
|
|
Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
Week 52 (N=107, 121)
|
3.7 Percentage of participants
Interval 1.53 to 8.64
|
2.2 Percentage of participants
Interval 0.72 to 6.75
|
|
Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
Week 76 (N=93, 96)
|
3.7 Percentage of participants
Interval 1.53 to 8.64
|
2.2 Percentage of participants
Interval 0.72 to 6.75
|
Adverse Events
Rabeprazole 5 mg
Serious events: 33 serious events
Other events: 89 other events
Deaths: 0 deaths
Rabeprazole10 mg
Serious events: 30 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rabeprazole 5 mg
n=201 participants at risk
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
|
Rabeprazole10 mg
n=204 participants at risk
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
|
|---|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Cardiac disorders
Angina pectoris
|
1.5%
3/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Eye disorders
Cataract
|
1.00%
2/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
General disorders
Chest discomfort
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
General disorders
Device dislocation
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Infections and infestations
Bronchitis
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Infections and infestations
Pharyngitis
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
1.00%
2/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Investigations
Blood pressure increased
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
2.0%
4/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Nervous system disorders
Brain stem infarction
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Nervous system disorders
Lacunar infarction
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Psychiatric disorders
Completed suicide
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Vascular disorders
Artery dissection
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.00%
0/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.50%
1/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
0.49%
1/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
Other adverse events
| Measure |
Rabeprazole 5 mg
n=201 participants at risk
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
|
Rabeprazole10 mg
n=204 participants at risk
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
11/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
7.8%
16/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
9/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
7.8%
16/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Infections and infestations
Nasopharyngitis
|
31.8%
64/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
27.9%
57/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
14/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
6.4%
13/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.5%
13/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
3.4%
7/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.0%
6/201 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
5.9%
12/204 • For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
|
Additional Information
Nobuyuki Sugisaki
Eisai Co., Ltd.
Phone: +81-3-3817-3908
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER