Trial Outcomes & Findings for A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection (NCT NCT01473836)
NCT ID: NCT01473836
Last Updated: 2014-01-24
Results Overview
Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
38 participants
Primary outcome timeframe
Baseline to EOT (up to 14 days), TOC
Results posted on
2014-01-24
Participant Flow
Participant milestones
| Measure |
Metronidazole/Ceftriaxone
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
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|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Metronidazole/Ceftriaxone
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
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|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Does not meet entrance criteria
|
1
|
Baseline Characteristics
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Baseline characteristics by cohort
| Measure |
Metronidazole/Ceftriaxone
n=38 Participants
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
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|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to EOT (up to 14 days), TOCPopulation: Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate".
Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Outcome measures
| Measure |
Metronidazole/Ceftriaxone
n=30 Participants
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
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|---|---|
|
Clinical Response: Response Rate (Data Review Committee Assessment)
End of Treatment (n=30)
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
|
Clinical Response: Response Rate (Data Review Committee Assessment)
Test of Cure (n=30)
|
96.7 percentage of participants
Interval 82.8 to 99.9
|
SECONDARY outcome
Timeframe: Baseline to EOT (up to 14 days), TOCPopulation: Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate".
Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Outcome measures
| Measure |
Metronidazole/Ceftriaxone
n=30 Participants
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
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|---|---|
|
Clinical Response: Response Rate (Investigator Assessment)
End of Treatment (n=30)
|
96.7 percentage of participants
Interval 82.8 to 99.9
|
|
Clinical Response: Response Rate (Investigator Assessment)
Test of Cure (n=29)
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate".
The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; "number of participants assessed as continuation" over "total number of participants that excluding ones assessed as indeterminate" multiplied by 100.
Outcome measures
| Measure |
Metronidazole/Ceftriaxone
n=30 Participants
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
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|---|---|
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Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Day 4, EOT (up to 14 days), TOCPopulation: Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate".
Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Outcome measures
| Measure |
Metronidazole/Ceftriaxone
n=21 Participants
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
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|---|---|
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Bacteriological Response: Eradication Rate (Data Review Committee Assessment)
Day 4
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
|
Bacteriological Response: Eradication Rate (Data Review Committee Assessment)
End of Treatment
|
100.0 percentage of participants
Interval 83.2 to 100.0
|
|
Bacteriological Response: Eradication Rate (Data Review Committee Assessment)
Test of Cure
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to Day 4, EOT (up to 14 days), TOCPopulation: Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate".
Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Outcome measures
| Measure |
Metronidazole/Ceftriaxone
n=21 Participants
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
|
|---|---|
|
Bacteriological Response: Eradication Rate (Investigator Assessment)
Day 4
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
|
Bacteriological Response: Eradication Rate (Investigator Assessment)
EOT
|
100.0 percentage of participants
Interval 83.2 to 100.0
|
|
Bacteriological Response: Eradication Rate (Investigator Assessment)
TOC
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
SECONDARY outcome
Timeframe: Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.Population: No population pharmacokinetic analysis results are available just for the current study.
Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.
Outcome measures
Outcome data not reported
Adverse Events
Metronidazole/Ceftriaxone
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metronidazole/Ceftriaxone
n=38 participants at risk
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
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|---|---|
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Infections and infestations
Infectious peritonitis
|
2.6%
1/38
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.
|
|
Infections and infestations
Pelvic inflammatory disease
|
2.6%
1/38
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
Intervertebral disc protrusion
|
2.6%
1/38
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal cancer
|
2.6%
1/38
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.
|
Other adverse events
| Measure |
Metronidazole/Ceftriaxone
n=38 participants at risk
Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
1/38
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.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.6%
1/38
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.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/38
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.
|
|
Cardiac disorders
Cardiac failure
|
2.6%
1/38
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.
|
|
Cardiac disorders
Sinus tachycardia
|
2.6%
1/38
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.
|
|
Cardiac disorders
Stress cardiomyopathy
|
2.6%
1/38
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.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.3%
2/38
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 discomfort
|
2.6%
1/38
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
|
7.9%
3/38
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
|
7.9%
3/38
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
|
5.3%
2/38
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
|
31.6%
12/38
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
Ileus
|
2.6%
1/38
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
Ileus paralytic
|
13.2%
5/38
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
Nausea
|
10.5%
4/38
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
Proctalgia
|
2.6%
1/38
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%
1/38
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
Vomiting
|
10.5%
4/38
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.
|
|
General disorders
Injection site extravasation
|
2.6%
1/38
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.
|
|
General disorders
Injection site pain
|
7.9%
3/38
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.
|
|
General disorders
Instillation site erythema
|
2.6%
1/38
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.
|
|
General disorders
Oedema
|
2.6%
1/38
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.
|
|
General disorders
Oedema peripheral
|
2.6%
1/38
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.
|
|
Infections and infestations
Injection site infection
|
2.6%
1/38
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.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/38
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.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma necrosis
|
2.6%
1/38
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.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.6%
1/38
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.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.6%
1/38
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.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
2.6%
1/38
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.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
1/38
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
|
2.6%
1/38
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
Aspartate aminotransferase increased
|
2.6%
1/38
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 glucose increased
|
5.3%
2/38
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 potassium increased
|
2.6%
1/38
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 pressure decreased
|
2.6%
1/38
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 sodium decreased
|
2.6%
1/38
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
Gamma-glutamyltransferase increased
|
2.6%
1/38
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
Haemoglobin decreased
|
2.6%
1/38
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
Platelet count increased
|
2.6%
1/38
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
2/38
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
1/38
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
1/38
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.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
2.6%
1/38
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
|
5.3%
2/38
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
Musculoskeletal pain
|
2.6%
1/38
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
Myalgia
|
2.6%
1/38
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
Dizziness
|
2.6%
1/38
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
Dysgeusia
|
2.6%
1/38
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.
|
|
Psychiatric disorders
Insomnia
|
13.2%
5/38
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.
|
|
Renal and urinary disorders
Dysuria
|
2.6%
1/38
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.
|
|
Renal and urinary disorders
Incontinence
|
2.6%
1/38
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.
|
|
Renal and urinary disorders
Renal impairment
|
2.6%
1/38
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/38
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
2/38
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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.6%
1/38
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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.6%
1/38
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/38
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.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
2.6%
1/38
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.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
5.3%
2/38
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