Trial Outcomes & Findings for Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) (NCT NCT00314951)
NCT ID: NCT00314951
Last Updated: 2017-04-21
Results Overview
Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
629 participants
Primary outcome timeframe
Study day 10 (+/- 2 days)
Results posted on
2017-04-21
Participant Flow
Subjects were enrolled from May 2006 to August 2008 by centers in the United States and Canada.
Participant milestones
| Measure |
Vancomycin
125 mg administered 4 times daily (q6hr)
|
Fidaxomicin
200 mg administered twice daily (q12hr)
|
|---|---|---|
|
Enrollment
STARTED
|
323
|
306
|
|
Enrollment
COMPLETED
|
323
|
300
|
|
Enrollment
NOT COMPLETED
|
0
|
6
|
|
Treatment
STARTED
|
323
|
300
|
|
Treatment
COMPLETED
|
307
|
289
|
|
Treatment
NOT COMPLETED
|
16
|
11
|
|
Follow-up
STARTED
|
307
|
289
|
|
Follow-up
COMPLETED
|
263
|
255
|
|
Follow-up
NOT COMPLETED
|
44
|
34
|
Reasons for withdrawal
| Measure |
Vancomycin
125 mg administered 4 times daily (q6hr)
|
Fidaxomicin
200 mg administered twice daily (q12hr)
|
|---|---|---|
|
Treatment
Didn't meet criteria for mITT population
|
16
|
11
|
|
Follow-up
mITT failure
|
44
|
34
|
Baseline Characteristics
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
Baseline characteristics by cohort
| Measure |
Vancomycin
n=307 Participants
125 mg administered 4 times daily (q6hr)
|
Fidaxomicin
n=289 Participants
200 mg administered twice daily (q12hr)
|
Total
n=596 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 16.9 • n=99 Participants
|
60.3 years
STANDARD_DEVIATION 16.9 • n=107 Participants
|
61.6 years
STANDARD_DEVIATION 16.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=99 Participants
|
164 Participants
n=107 Participants
|
333 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
263 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
186 participants
n=99 Participants
|
165 participants
n=107 Participants
|
351 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
121 participants
n=99 Participants
|
124 participants
n=107 Participants
|
245 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Study day 10 (+/- 2 days)Population: Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by \>3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.
Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
Outcome measures
| Measure |
Vancomycin
n=307 Participants
125 mg administered 4 times daily (q6hr)
|
Fidaxomicin
n=289 Participants
200 mg administered twice daily (q12hr)
|
|---|---|---|
|
Cure Rate at End of Therapy
|
85.7 Percentage of Participants
Interval 81.3 to 89.2
|
88.2 Percentage of Participants
Interval 84.0 to 91.5
|
SECONDARY outcome
Timeframe: Study days 11-40Population: The mITT population for subjects who met the primary endpoint of cure subjects, were analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.
Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.
Outcome measures
| Measure |
Vancomycin
n=263 Participants
125 mg administered 4 times daily (q6hr)
|
Fidaxomicin
n=255 Participants
200 mg administered twice daily (q12hr)
|
|---|---|---|
|
Recurrence
|
25.1 Percentage of Participants
|
15.7 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Study (Day 40)Population: The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.
Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.
Outcome measures
| Measure |
Vancomycin
n=307 Participants
125 mg administered 4 times daily (q6hr)
|
Fidaxomicin
n=289 Participants
200 mg administered twice daily (q12hr)
|
|---|---|---|
|
Global Cure
|
64.2 Percentage of Participants
|
74.4 Percentage of Participants
|
Adverse Events
Vancomycin
Serious events: 78 serious events
Other events: 195 other events
Deaths: 0 deaths
Fidaxomicin
Serious events: 75 serious events
Other events: 187 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vancomycin
n=323 participants at risk
125 mg administered 4 times daily (q6hr)
|
Fidaxomicin
n=300 participants at risk
200 mg administered twice daily (q12hr)
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.3%
4/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.3%
4/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Cardiogenic shock
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Myocardial infarction
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.0%
3/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Atrial flutter
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Cardiac arrest
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Cor pulmonale
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Congenital, familial and genetic disorders
Cleft palate
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Ascites
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.3%
4/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Ileus
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Peritonitis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Chest pain
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Malaise
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Pyrexia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Generalised oedema
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Hypothermia
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Impaired healing
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Multi-organ failure
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Oedema peripheral
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.9%
6/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.0%
3/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Pneumonia
|
1.5%
5/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.3%
4/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Sepsis
|
0.93%
3/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.0%
3/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Urosepsis
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Aspergillosis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Bacteraemia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Endocarditis bacterial
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Enterocolitis infectious
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Escherichia sepsis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Meningitis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Postoperative wound infection
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Pyelocystitis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Septic shock
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Systemic candida
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Shunt infection
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Graft haemorrhage
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood glucose abnormal
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood phosphorus decreased
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood uric acid increased
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.0%
3/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Lymphocyte count decreased
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
White blood cell count decreased
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood calcium increased
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood phosphorus abnormal
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood urea abnormal
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Blood uric acid abnormal
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Investigations
Platelet count decreased
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
4/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
3/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.93%
3/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.93%
3/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.0%
3/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.0%
3/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer metastatic
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Nervous system disorders
Coma
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Nervous system disorders
Syncope
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Psychiatric disorders
Mental status changes
|
0.93%
3/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Psychiatric disorders
Confusional state
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Renal and urinary disorders
Renal failure
|
0.93%
3/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Renal and urinary disorders
Renal failure acute
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.3%
4/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
3/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.93%
3/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Haemopneumothorax
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Vascular disorders
Deep vein thrombosis
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Vascular disorders
Haemorrhage
|
0.31%
1/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.00%
0/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Vascular disorders
Hypotension
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
Other adverse events
| Measure |
Vancomycin
n=323 participants at risk
125 mg administered 4 times daily (q6hr)
|
Fidaxomicin
n=300 participants at risk
200 mg administered twice daily (q12hr)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
7/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
3.3%
10/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
28/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
10.3%
31/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
14/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
6.0%
18/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
12/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
3.0%
9/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
7/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
3.0%
9/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
4/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
3.3%
10/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Oedema peripheral
|
5.3%
17/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
4.3%
13/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Pyrexia
|
5.0%
16/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
5.3%
16/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Chills
|
2.5%
8/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.33%
1/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Fatigue
|
1.9%
6/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.0%
6/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
General disorders
Pain
|
1.5%
5/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.0%
6/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
12/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
4.0%
12/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Infections and infestations
Pneumonia
|
2.5%
8/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.0%
6/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
5/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.0%
6/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
24/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
7.3%
22/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
9/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.0%
6/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.8%
9/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.7%
5/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.9%
6/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
3.0%
9/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
5/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.3%
7/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
4/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.7%
8/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.0%
6/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Nervous system disorders
Headache
|
4.3%
14/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
6.7%
20/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Nervous system disorders
Dizziness
|
1.2%
4/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
4.0%
12/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Psychiatric disorders
Insomnia
|
2.8%
9/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
1.7%
5/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Renal and urinary disorders
Renal failure acute
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.0%
6/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
9/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
3.7%
11/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
7/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
0.67%
2/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.62%
2/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
3.0%
9/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
|
Vascular disorders
Hypotension
|
1.9%
6/323 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
2.3%
7/300 • From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60