Trial Outcomes & Findings for Study Of Celecoxib In Healthy Subjects (NCT NCT00994461)
NCT ID: NCT00994461
Last Updated: 2021-02-02
Results Overview
The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
190 participants
Primary outcome timeframe
2 weeks
Results posted on
2021-02-02
Participant Flow
Subjects were screened at 3 centers in Japan.
Participant milestones
| Measure |
Celecoxib
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
37
|
|
Overall Study
COMPLETED
|
74
|
75
|
37
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Celecoxib
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
Baseline Characteristics
Study Of Celecoxib In Healthy Subjects
Baseline characteristics by cohort
| Measure |
Celecoxib
n=76 Participants
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 Participants
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 Participants
Placebo tablet three times a day with meal for 2 weeks
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.5 Years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
57.8 Years
STANDARD_DEVIATION 9.38 • n=7 Participants
|
59.1 Years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 9.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Helicobacter pylori (H. pylori) status
Positive
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Helicobacter pylori (H. pylori) status
Negative
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: The modified-safety analysis set (m-SAF) consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.
The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.
Outcome measures
| Measure |
Celecoxib
n=74 Participants
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 Participants
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 Participants
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Incidence of Gastroduodenal Ulcers
|
1.4 Percent
|
27.6 Percent
|
2.7 Percent
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.
The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.
Outcome measures
| Measure |
Celecoxib
n=74 Participants
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 Participants
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 Participants
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Incidence of Any Gastric, and Duodenal Ulcers
Gastric ulcers
|
0 Percent
|
25.0 Percent
|
2.7 Percent
|
|
Incidence of Any Gastric, and Duodenal Ulcers
Duodenal ulcers
|
1.4 Percent
|
5.3 Percent
|
0 Percent
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.
The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.
Outcome measures
| Measure |
Celecoxib
n=74 Participants
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 Participants
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 Participants
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions
Gastroduodenal ulcers and/or erosions
|
36.5 Percent
|
53.9 Percent
|
24.3 Percent
|
|
Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions
Gastric ulcers and/or erosions
|
35.1 Percent
|
53.9 Percent
|
24.3 Percent
|
|
Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions
Duodenal ulcers and/or erosions
|
4.1 Percent
|
5.3 Percent
|
0 Percent
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.
Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)
Outcome measures
| Measure |
Celecoxib
n=74 Participants
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 Participants
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 Participants
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Score 0
|
38 Participants
|
33 Participants
|
22 Participants
|
|
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Score 1
|
8 Participants
|
2 Participants
|
6 Participants
|
|
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Score 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Score 3
|
22 Participants
|
19 Participants
|
8 Participants
|
|
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Score 4
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Score 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Score 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Score 7
|
1 Participants
|
21 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.
Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)
Outcome measures
| Measure |
Celecoxib
n=74 Participants
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 Participants
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 Participants
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Number of Gastroduodenal Ulcers in Each Subject
0 ulcer
|
73 Participants
|
55 Participants
|
36 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
1 ulcer
|
1 Participants
|
10 Participants
|
1 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
2 ulcers
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
3 ulcers
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
4 ulcers
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
5 ulcers
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
6 ulcers
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
7 ulcers
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
8 ulcers
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
9 ulcers
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Gastroduodenal Ulcers in Each Subject
10 or more ulcers
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.
Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)
Outcome measures
| Measure |
Celecoxib
n=74 Participants
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 Participants
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 Participants
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Number of Gastroduodenal Erosions in Each Subject
0 erosion
|
47 Participants
|
41 Participants
|
29 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
1 erosion
|
14 Participants
|
13 Participants
|
5 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
2 erosions
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
3 erosions
|
5 Participants
|
9 Participants
|
2 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
4 erosions
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
5 erosions
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
6 erosions
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
7 erosions
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
8 erosions
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
9 erosions
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Gastroduodenal Erosions in Each Subject
10 or more erosions
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.
The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)
Outcome measures
| Measure |
Celecoxib
n=74 Participants
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 Participants
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 Participants
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Incidence of Treatment-emergent, All-causality GI Body System Adverse Events
|
24.3 Percent
|
47.4 Percent
|
16.2 Percent
|
Adverse Events
Celecoxib
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Loxoprofen
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Celecoxib
n=76 participants at risk
Celecoxib 100 mg tablet twice a day with meal for 2 weeks
|
Loxoprofen
n=76 participants at risk
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
|
Placebo
n=37 participants at risk
Placebo tablet three times a day with meal for 2 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
4/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.9%
3/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
1/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.4%
2/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
1/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.3%
1/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
1.3%
1/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.6%
5/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
4/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
1/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis erosive
|
10.5%
8/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
36.8%
28/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.1%
3/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
1/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
2/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
1/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
1/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
1/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
1.3%
1/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
4/76 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/37 • 2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER