Trial Outcomes & Findings for Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate] (NCT NCT02151786)
NCT ID: NCT02151786
Last Updated: 2016-02-23
Results Overview
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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.
COMPLETED
1120 participants
Baseline up to Week 9
2016-02-23
Participant Flow
Participants took part in the study at 173 investigative site in Japan from 29 January 2007 to 31 March 2010.
In this study, participants were observed with a historical diagnosis of gastric ulcer or duodenal ulcer or acute stress ulcer or acute gastric mucosal lesion accompanied with bleeding, for whom oral administration of drug was not feasible and were enrolled in single treatment group: Lansoprazole.
Participant milestones
| Measure |
Lansoprazole
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Overall Study
STARTED
|
1120
|
|
Overall Study
COMPLETED
|
1084
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Lansoprazole
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Overall Study
Unavailability of Case Report Form
|
26
|
|
Overall Study
Outside the Contract Period
|
1
|
|
Overall Study
Randomized, not Treated
|
1
|
|
Overall Study
Unavailability of Information
|
8
|
Baseline Characteristics
Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]
Baseline characteristics by cohort
| Measure |
Lansoprazole
n=1084 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 14.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
350 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
734 Participants
n=5 Participants
|
|
Pregnancy Status
Not Pregnant
|
349 participants
n=5 Participants
|
|
Pregnancy Status
Pregnant
|
0 participants
n=5 Participants
|
|
Pregnancy Status
Unknown
|
1 participants
n=5 Participants
|
|
Target Diseases
Gastric Ulcer
|
768 participants
n=5 Participants
|
|
Target Diseases
Duodenal Ulcer
|
221 participants
n=5 Participants
|
|
Target Diseases
Gastroduodenal Ulcer
|
23 participants
n=5 Participants
|
|
Target Diseases
Acute Stress-Induced Ulcer
|
8 participants
n=5 Participants
|
|
Target Diseases
Acute Gastric Mucosal Lesion
|
60 participants
n=5 Participants
|
|
Target Diseases
Not Provided
|
4 participants
n=5 Participants
|
|
Categories of Healthcare
Outpatient
|
11 participants
n=5 Participants
|
|
Categories of Healthcare
Inpatient
|
1073 participants
n=5 Participants
|
|
Predisposition to Hypersensitivity
No
|
1042 participants
n=5 Participants
|
|
Predisposition to Hypersensitivity
Yes
|
39 participants
n=5 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
3 participants
n=5 Participants
|
|
Helicobacter pylori Infection
Negative
|
199 participants
n=5 Participants
|
|
Helicobacter pylori Infection
Positive
|
434 participants
n=5 Participants
|
|
Helicobacter pylori Infection
Unknown
|
451 participants
n=5 Participants
|
|
Alcohol Consumption
Alcohol Consumer
|
382 participants
n=5 Participants
|
|
Alcohol Consumption
Alcohol Non-Consumer
|
547 participants
n=5 Participants
|
|
Alcohol Consumption
Unknown
|
155 participants
n=5 Participants
|
|
Smoking Status
Smoker
|
317 participants
n=5 Participants
|
|
Smoking Status
Non-Smoker
|
599 participants
n=5 Participants
|
|
Smoking Status
Unknown
|
168 participants
n=5 Participants
|
|
Medical History
Have Medical History
|
574 participants
n=5 Participants
|
|
Medical History
Did not Have Medical History
|
510 participants
n=5 Participants
|
|
Breakdown of Medical History
Peptic Ulcer
|
241 participants
n=5 Participants
|
|
Breakdown of Medical History
Upper gastrointestinal bleeding
|
97 participants
n=5 Participants
|
|
Breakdown of Medical History
Cerebrovascular accident
|
64 participants
n=5 Participants
|
|
Breakdown of Medical History
Malignant Tumor
|
59 participants
n=5 Participants
|
|
Breakdown of Medical History
Hypertension
|
55 participants
n=5 Participants
|
|
Breakdown of Medical History
Cardiac Disorders
|
55 participants
n=5 Participants
|
|
Breakdown of Medical History
Hepatic Dysfunction
|
42 participants
n=5 Participants
|
|
Breakdown of Medical History
Diabetes Mellitus
|
37 participants
n=5 Participants
|
|
Breakdown of Medical History
Renal Dysfunction
|
13 participants
n=5 Participants
|
|
Breakdown of Medical History
Other
|
187 participants
n=5 Participants
|
|
Complications
Had Complications
|
632 participants
n=5 Participants
|
|
Complications
Had no Complications
|
452 participants
n=5 Participants
|
|
Breakdown of Complications
Hypertension
|
206 participants
n=5 Participants
|
|
Breakdown of Complications
Cardiac Disorders
|
121 participants
n=5 Participants
|
|
Breakdown of Complications
Diabetes Mellitus
|
118 participants
n=5 Participants
|
|
Breakdown of Complications
Hepatic Dysfunction
|
115 participants
n=5 Participants
|
|
Breakdown of Complications
Anemia
|
78 participants
n=5 Participants
|
|
Breakdown of Complications
Malignant Tumor
|
68 participants
n=5 Participants
|
|
Breakdown of Complications
Cerebrovascular Accident
|
66 participants
n=5 Participants
|
|
Breakdown of Complications
Renal Dysfunction
|
61 participants
n=5 Participants
|
|
Breakdown of Complications
Other
|
351 participants
n=5 Participants
|
|
Emotional Stress
Had Stress
|
129 participants
n=5 Participants
|
|
Emotional Stress
Had no Stress
|
955 participants
n=5 Participants
|
|
Prior Consumption of Drugs Affecting Coagulation System
No
|
758 participants
n=5 Participants
|
|
Prior Consumption of Drugs Affecting Coagulation System
Yes
|
325 participants
n=5 Participants
|
|
Prior Consumption of Drugs Affecting Coagulation System
Unknown
|
1 participants
n=5 Participants
|
|
Breakdown of Drugs
Non Steroidal Anti-Inflammatory Drugs
|
158 participants
n=5 Participants
|
|
Breakdown of Drugs
Platelet aggregation inhibitors
|
152 participants
n=5 Participants
|
|
Breakdown of Drugs
Anticoagulants
|
49 participants
n=5 Participants
|
|
Breakdown of Drugs
Steroids
|
31 participants
n=5 Participants
|
|
Breakdown of Drugs
Other
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 9Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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.
Outcome measures
| Measure |
Lansoprazole
n=1084 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Number of Participants Reporting One or More Adverse Drug Reactions
|
35 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 9Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Lansoprazole
n=1084 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Number of Participants Reporting One or More Serious Adverse Drug Reactions
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 9Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.
Outcome measures
| Measure |
Lansoprazole
n=1052 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Percentage of Participants With Observed Hemostatic Effect
|
90.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 9Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.
Outcome measures
| Measure |
Lansoprazole
n=898 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Percentage of Participants With Confirmed Hemostatic Effect
|
91.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 9Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.
Outcome measures
| Measure |
Lansoprazole
n=819 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect
|
1.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 9Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.
Outcome measures
| Measure |
Lansoprazole
n=745 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect
|
1.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 after the last dose of study drug (Week 17)Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.
Outcome measures
| Measure |
Lansoprazole
n=497 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
|
5.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 after the last dose of study drug (Week 17)Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.
Outcome measures
| Measure |
Lansoprazole
n=389 Participants
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
|
7.1 percentage of participants
|
Adverse Events
Lansoprazole
Serious adverse events
| Measure |
Lansoprazole
n=1084 participants at risk
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Psychiatric disorders
Insomnia
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Psychiatric disorders
Restlessness
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Psychiatric disorders
Depressive Symptom
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.37%
4/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
White blood cell count decreased
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
Other adverse events
| Measure |
Lansoprazole
n=1084 participants at risk
Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Psychiatric disorders
Insomnia
|
0.18%
2/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Psychiatric disorders
Restlessness
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Psychiatric disorders
Depressive symptom
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Hypogeusia
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Constipation
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
3/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.65%
7/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.28%
3/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.28%
3/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.18%
2/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Pyrexia
|
0.28%
3/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Eosinophil count increased
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Platelet count decreased
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
White blood cell count decreased
|
0.28%
3/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Blood creatinine increased
|
0.09%
1/1084 • Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
Additional Information
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