Trial Outcomes & Findings for AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD) (NCT NCT00240331)
NCT ID: NCT00240331
Last Updated: 2011-05-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2776 participants
Primary outcome timeframe
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Results posted on
2011-05-19
Participant Flow
Recruited patients were male or female with end-stage renal failure aged 50 to 80 years, who had received regular chronic haemodialysis treatment (including haemofiltration and hemodiafiltration ) for at least 3 months. They were recruited from 280 sites in 25 countries; recruitment started on 16 January 2003 and finished on 24 November 2004.
After a two week screening period, eligible patients were randomly assigned to either rosuvastatin treatment (10mg/day) or placebo with a 1:1 randomisation ratio. Follow-up was planned to continue until the accrual of 805 major cardiovascular events
Participant milestones
| Measure |
Rosuvastatin 10mg
Rosuvastatin 10 mg oral tablets
|
Placebo
Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
1389
|
1384
|
|
Overall Study
COMPLETED
|
1263
|
1250
|
|
Overall Study
NOT COMPLETED
|
126
|
134
|
Reasons for withdrawal
| Measure |
Rosuvastatin 10mg
Rosuvastatin 10 mg oral tablets
|
Placebo
Matching placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
125
|
132
|
|
Overall Study
Option selected by investigator
|
1
|
2
|
Baseline Characteristics
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
Baseline characteristics by cohort
| Measure |
Rosuvastatin 10mg
n=1389 Participants
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1384 Participants
Matching placebo
|
Total
n=2773 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.1 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
64.3 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
64.2 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
538 Participants
n=5 Participants
|
512 Participants
n=7 Participants
|
1050 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
851 Participants
n=5 Participants
|
872 Participants
n=7 Participants
|
1723 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 yearsOutcome measures
| Measure |
Rosuvastatin 10mg
n=1389 Participants
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1384 Participants
Matching placebo
|
|---|---|---|
|
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
|
396 Participants
|
408 Participants
|
SECONDARY outcome
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 yearsOutcome measures
| Measure |
Rosuvastatin 10mg
n=1389 Participants
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1384 Participants
Matching placebo
|
|---|---|---|
|
Number of Randomised Participants That Died From Any Cause.
|
636 Participants
|
660 Participants
|
SECONDARY outcome
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 yearsOutcome measures
| Measure |
Rosuvastatin 10mg
n=1389 Participants
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1384 Participants
Matching placebo
|
|---|---|---|
|
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
|
614 Participants
|
645 Participants
|
SECONDARY outcome
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 yearsOutcome measures
| Measure |
Rosuvastatin 10mg
n=1389 Participants
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1384 Participants
Matching placebo
|
|---|---|---|
|
Number of Randomised Participants That Died From Cardiovascular Cause
|
324 Participants
|
324 Participants
|
SECONDARY outcome
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 yearsOutcome measures
| Measure |
Rosuvastatin 10mg
n=1389 Participants
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1384 Participants
Matching placebo
|
|---|---|---|
|
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
|
258 Participants
|
256 Participants
|
SECONDARY outcome
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 yearsOutcome measures
| Measure |
Rosuvastatin 10mg
n=1389 Participants
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1384 Participants
Matching placebo
|
|---|---|---|
|
Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.
|
390 Participants
|
360 Participants
|
SECONDARY outcome
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 yearsOutcome measures
| Measure |
Rosuvastatin 10mg
n=1389 Participants
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1384 Participants
Matching placebo
|
|---|---|---|
|
Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
|
148 Participants
|
152 Participants
|
Adverse Events
Rosuvastatin 10mg
Serious events: 1140 serious events
Other events: 620 other events
Deaths: 0 deaths
Placebo
Serious events: 1159 serious events
Other events: 635 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin 10mg
n=1389 participants at risk
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1378 participants at risk
Matching placebo
|
|---|---|---|
|
Infections and infestations
Escherichia Sepsis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Orchitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Catheter Related Infection
|
1.0%
14/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.1%
15/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Wound Necrosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Gait Disturbance
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Catheter Site Haematoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Catheter Site Inflammation
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Haemorrhagic Cyst
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Hyperpyrexia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Ulcer Haemorrhage
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Chest Discomfort
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Drug Interaction
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Hypothermia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Influenza Like Illness
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Arteriovenous Fistula Site Infection
|
1.1%
15/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.94%
13/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Necrosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Pain
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.65%
9/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Biliary Dilatation
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Cholangitis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Gallbladder Perforation
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Hepatic Cyst
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Hepatitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Hepatitis Toxic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Biliary Colic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Hepatic Necrosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Hepatobiliary disorders
Portal Vein Occlusion
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Immune system disorders
Amyloidosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Immune system disorders
Kidney Transplant Rejection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Immune system disorders
Anaphylactic Shock
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pneumonia
|
6.6%
92/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
7.0%
96/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Sepsis
|
4.7%
65/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
5.1%
70/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bronchitis
|
1.4%
20/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.6%
22/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bronchopneumonia
|
1.4%
19/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.3%
18/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
19/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.87%
12/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
16/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Lung Infection
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Gangrene
|
0.72%
10/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.0%
14/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Septic Shock
|
0.94%
13/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Cellulitis
|
0.79%
11/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.80%
11/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.72%
10/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.80%
11/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Arthritis Bacterial
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bacteraemia
|
0.65%
9/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Lobar Pneumonia
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Localised Infection
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Diverticulitis
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Erysipelas
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Viral Infection
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Catheter Sepsis
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Endocarditis
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Infection
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Infected Skin Ulcer
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Appendicitis
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Arteriovenous Graft Site Infection
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Osteomyelitis
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Shunt Infection
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Staphylococcal Infection
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Central Line Infection
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Wound Infection
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Catheter Site Infection
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Graft Infection
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Herpes Zoster
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Intervertebral Discitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Arthritis Infective
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bacterial Infection
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Device Related Infection
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Post Procedural Infection
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Postoperative Abscess
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Renal Cyst Infection
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Abscess Limb
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bacterial Sepsis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Diabetic Gangrene
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Empyema
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Endocarditis Bacterial
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Enterococcal Sepsis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Hepatic Cyst Infection
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Influenza
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Meningitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pyelonephritis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pyonephrosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Skin Infection
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Cytomegalovirus Infection
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Escherichia Infection
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Tooth Infection
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Abscess
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Abscess Intestinal
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Abscess Neck
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Arteriosclerotic Gangrene
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bone Abscess
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Candida Sepsis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Febrile Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Fungal Sepsis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Gallbladder Abscess
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Gallbladder Empyema
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Haemophilus Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Helicobacter Gastritis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Hypopyon
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Klebsiella Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Klebsiella Sepsis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Listeriosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Liver Abscess
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Myocarditis Septic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pancreas Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pelvic Abscess
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Penile Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Perinephric Abscess
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Peritoneal Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pneumonia Moraxella
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pyothorax
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Rectal Abscess
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Scrotal Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Sepsis Syndrome
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Streptococcal Bacteraemia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Streptococcal Infection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Tuberculosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Urinary Tract Infection Staphylococcal
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Urosepsis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Abdominal Infection
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Abdominal Sepsis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bronchitis Viral
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Chronic Tonsillitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Citrobacter Sepsis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Clostridial Infection
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Clostridium Colitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Diabetic Foot Infection
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Diarrhoea Infectious
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Endocarditis Staphylococcal
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Enteritis Infectious
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Eye Infection
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Fungal Infection
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Furuncle
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Herpes Simplex
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Infective Exacerbation Of Chronic Obstructive Airways Disease
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Infective Spondylitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Lung Abscess
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Lung Infection Pseudomonal
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Meningitis Bacterial
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Otitis Externa
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Otitis Media
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Peridiverticular Abscess
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Perihepatic Abscess
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Peritonitis Bacterial
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pneumococcal Sepsis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pneumonia Klebsiella
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Respiratory Tract Infection Bacterial
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Sinusitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Toxoplasmosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Tuberculous Pleurisy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Urinary Tract Infection Pseudomonal
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
3.9%
54/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
4.4%
60/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
3.8%
53/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
3.3%
45/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
2.2%
30/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
2.9%
40/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Haemorrhage
|
1.4%
20/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.7%
24/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.4%
19/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Aneurysm
|
0.94%
13/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.3%
18/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.94%
13/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.0%
14/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Shunt Thrombosis
|
0.86%
12/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Shunt Stenosis
|
0.79%
11/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Vascular Graft Complication
|
0.79%
11/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Graft Thrombosis
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Graft Thrombosis
|
0.72%
10/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Occlusion
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.65%
9/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Haemodialysis-Induced Symptom
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Shunt Occlusion
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Wound
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Haematoma
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Graft Aneurysm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Pubic Rami Fracture
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Graft Site Haemorrhage
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Complications Of Transplanted Kidney
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Shunt Malfunction
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Vascular Procedure Complication
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Graft Site Haematoma
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Dialysis Device Complication
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Injury
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Acetabulum Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Cerebral Haemorrhage Traumatic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Convulsion
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Nephrogenic Anaemia
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Haemorrhagic Diathesis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Splenic Infarction
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Anaemia Megaloblastic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Lymphadenopathy Mediastinal
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Myocardial Infarction
|
3.8%
53/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
3.8%
52/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.8%
39/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
3.3%
45/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiac Failure
|
2.2%
30/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
2.5%
35/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Angina Pectoris
|
1.5%
21/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
2.2%
31/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiac Arrest
|
1.6%
22/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.9%
26/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.94%
13/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.87%
12/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Bradycardia
|
0.86%
12/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Angina Unstable
|
0.65%
9/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.72%
10/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.72%
10/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Arrhythmia
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.65%
9/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Tachycardia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Atrioventricular Block
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Atrial Flutter
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiac Asthma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Hypertensive Cardiomyopathy
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Pericarditis
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Palpitations
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Pericarditis Constrictive
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Prinzmetal Angina
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Silent Myocardial Infarction
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Sinus Arrhythmia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Trifascicular Block
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Cardiac Failure High Output
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Nodal Rhythm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Pericardial Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Torsade De Pointes
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia Haemorrhagic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Congenital, familial and genetic disorders
Polycystic Liver Disease
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Congenital, familial and genetic disorders
Pyloric Stenosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Ear and labyrinth disorders
Vertigo
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Endocrine disorders
Hyperparathyroidism
|
1.3%
18/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Endocrine disorders
Hyperparathyroidism Secondary
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Endocrine disorders
Hyperparathyroidism Tertiary
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Endocrine disorders
Hypopituitarism
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Cataract
|
1.2%
16/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.80%
11/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Angle Closure Glaucoma
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Glaucoma
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Papilloedema
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Retinopathy
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Diabetic Retinopathy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Diplopia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Endophthalmitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Eye Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Eye disorders
Retinal Artery Occlusion
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.8%
25/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.3%
18/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.2%
17/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.87%
12/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
13/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastritis
|
0.65%
9/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Peritonitis
|
0.65%
9/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Melaena
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Haematemesis
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Ileus
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Colitis
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Subileus
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Constipation
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Abdominal Symptom
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intra-Abdominal Haemorrhage
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Ascites
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intestinal Infarction
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Nausea
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Colonic Pseudo-Obstruction
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Faecaloma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastric Stenosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastrointestinal Ischaemia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Haematochezia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intestinal Angina
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intra-Abdominal Haematoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Mechanical Ileus
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Mesenteric Artery Embolism
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Mesenteric Vascular Insufficiency
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Oesophagitis Haemorrhagic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Pancreatic Cyst
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Periodontitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Proctocolitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Rectal Polyp
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Sclerosing Encapsulating Peritonitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Dental Caries
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Diarrhoea Haemorrhagic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Duodenitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Intestinal Strangulation
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Large Intestinal Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Mesenteric Artery Stenosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Mesenteric Artery Thrombosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Oesophageal Ulcer
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Peritoneal Effusion
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Retroperitoneal Effusion
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Sudden Death
|
2.4%
33/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
2.2%
30/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Death
|
2.2%
30/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
2.2%
30/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Catheter Related Complication
|
1.0%
14/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.2%
17/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Pyrexia
|
0.94%
13/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.1%
15/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Catheter Thrombosis
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Malaise
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Sudden Cardiac Death
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Catheter Site Haemorrhage
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
General Physical Health Deterioration
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Chest Pain
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Asthenia
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Cardiac Death
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Chills
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Discomfort
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Fatigue
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Inflammation
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Multi-Organ Failure
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
General disorders
Oedema Peripheral
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Spondylitic Myelopathy
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Status Epilepticus
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Stupor
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Altered State Of Consciousness
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Amnesia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Anoxic Encephalopathy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Arachnoid Cyst
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Brain Compression
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebral Disorder
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Diabetic Autonomic Neuropathy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Hemiparesis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Hydrocephalus
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Hypoaesthesia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Intracranial Haematoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Intraventricular Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Monoparesis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Parkinson's Disease
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Presenile Dementia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Quadriparesis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Simple Partial Seizures
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Vascular Dementia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Confusional State
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Delirium
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Sleep Disorder
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Alcohol Abuse
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Anxiety
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Disorientation
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Impaired Self-Care
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Delusional Disorder, Persecutory Type
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Insomnia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Mental Disorder
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Psychotic Disorder Due To A General Medical Condition
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.65%
9/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Haematuria
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Azotaemia
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Renal Haemorrhage
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Renal Failure
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Calculus Bladder
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Renal Cyst
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Extravasation Of Urine
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Calculus Urethral
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Renal Cyst Ruptured
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Renal and urinary disorders
Urinary Bladder Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Prostatism
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Endometrial Hypertrophy
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Balanitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.94%
13/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.8%
25/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
19/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.6%
22/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.3%
18/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.0%
14/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.80%
11/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Foreign Body Aspiration
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arterial Insufficiency
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Fistula
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Consolidation
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Necrosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Wegener's Granulomatosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.79%
11/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Diabetic Ulcer
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Cutaneous Vasculitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Dry Gangrene
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Nail Discolouration
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Refusal Of Treatment By Patient
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arterial Bypass Operation
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Catheter Placement
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Chemotherapy Neurotoxicity Attenuation
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Parathyroidectomy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Peripheral Ischaemia
|
1.7%
24/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.0%
14/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Hypotension
|
1.0%
14/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
1.5%
20/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
1.1%
15/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Hypertension
|
0.79%
11/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.80%
11/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Hypertensive Crisis
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Extremity Necrosis
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arteriosclerosis
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Haematoma
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Aortic Aneurysm
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arteritis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Aortic Aneurysm Rupture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Cardiovascular Insufficiency
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Shock
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Venous Stenosis
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Aortic Stenosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Circulatory Collapse
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Intermittent Claudication
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Steal Syndrome
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Superior Vena Caval Stenosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Venous Occlusion
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arterial Stenosis Limb
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Aneurysm Ruptured
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Aortic Dissection
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arterial Disorder
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arterial Stenosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Arteriosclerosis Obliterans
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Blue Toe Syndrome
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Diabetic Vascular Disorder
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Hypertensive Emergency
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Ischaemic Limb Pain
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Necrosis Ischaemic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Poor Peripheral Circulation
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Shock Haemorrhagic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Vascular Calcification
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Venous Aneurysm
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Aortic Occlusion
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Lymphocele
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Peripheral Embolism
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Secondary Hypertension
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Thrombosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Vasculitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Venous Thrombosis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Chest Injury
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Extrusion Of Device
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Foreign Body Trauma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Graft Complication
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Graft Haemorrhage
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Heat Illness
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Medical Device Complication
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Medical Device Pain
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Narcotic Intoxication
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Periorbital Haematoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Perirenal Haematoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Post Procedural Fistula
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Shunt Aneurysm
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Skeletal Injury
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Cardiac Pacemaker Malfunction
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Cardiac Procedure Complication
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Collapse Of Lung
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Comminuted Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Dialysis Disequilibrium Syndrome
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Dislocation Of Joint Prosthesis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Dislocation Of Vertebra
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Fractured Sacrum
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Haemolytic Transfusion Reaction
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Ilium Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Pacemaker Complication
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Peripheral Nerve Injury
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Procedural Vomiting
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Stent-Graft Endoleak
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Suture Related Complication
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Transfusion Reaction
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Traumatic Intracranial Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Vascular Injury
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Venous Injury
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
International Normalised Ratio Increased
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Blood Calcium Decreased
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Blood Pressure Increased
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Blood Glucose Increased
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
C-Reactive Protein Increased
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Electrocardiogram Q Wave Abnormal
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Electrocardiogram T Wave Inversion
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Occult Blood Positive
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Urine Cytology Abnormal
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Alanine Aminotransferase Increased
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Blood Creatinine Increased
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Blood Culture Positive
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Blood Potassium Increased
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Electrocardiogram T Wave Amplitude Increased
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Haemoglobin Decreased
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Liver Function Test Abnormal
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.94%
13/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Diabetic Foot
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.87%
12/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.44%
6/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Gout
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.58%
8/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.36%
5/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.50%
7/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Haemorrhage
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Bone Cyst
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's Contracture
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Space Narrowing
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Nodal Osteoarthritis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Osteitis Deformans
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.29%
4/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip Neoplasm Malignant Stage Unspecified
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid Cancer
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma Stage Iii
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epiglottic Carcinoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer Metastatic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer Stage Iii
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Malignant Melanoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pain
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Renal Cell Carcinoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Oncocytoma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Breast Neoplasm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Lung Neoplasm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm Of Testis
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Small Intestinal Neoplasm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Papilloma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Neoplasm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Female
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Of The Stomach
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid Melanoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Stage I
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicle Centre Lymphoma, Follicular Grade I, Ii, Iii Stage I
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Tract Adenoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Unspecified
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic Lymphoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Carcinoma Of The Bladder
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Metastatic
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Recurrent
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.2%
30/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
2.1%
29/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.72%
10/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.73%
10/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Syncope
|
0.72%
10/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.51%
7/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.65%
9/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.43%
6/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.58%
8/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebral Infarction
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.36%
5/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.29%
4/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Epilepsy
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.22%
3/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Headache
|
0.22%
3/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Dysarthria
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Hypoglycaemic Coma
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Loss Of Consciousness
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Sciatica
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Somnolence
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.15%
2/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Carotid Arteriosclerosis
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebellar Haemorrhage
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Coma
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Dementia
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Uraemic Encephalopathy
|
0.14%
2/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.00%
0/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Brain Oedema
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebral Arteriosclerosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebral Artery Thrombosis
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cervical Cord Compression
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Coma Hepatic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Coma Uraemic
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Encephalopathy
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Lacunar Infarction
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Nervous System Disorder
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Neuralgia
|
0.07%
1/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Neurodegenerative Disorder
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
0.07%
1/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
Other adverse events
| Measure |
Rosuvastatin 10mg
n=1389 participants at risk
Rosuvastatin 10 mg oral tablets
|
Placebo
n=1378 participants at risk
Matching placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
Haemodialysis-Induced Symptom
|
5.7%
79/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
5.7%
78/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.8%
81/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
4.5%
62/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
70/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
4.3%
59/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.5%
202/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
13.6%
188/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
112/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
9.2%
127/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
121/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
7.0%
97/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
82/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
5.8%
80/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.8%
80/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
5.4%
74/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Bronchitis
|
9.3%
129/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
9.7%
133/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
127/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
8.4%
116/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Infections and infestations
Urinary Tract Infection
|
6.6%
92/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
6.0%
83/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
9.4%
131/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
9.5%
131/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
5.5%
76/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
5.4%
75/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
110/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
6.7%
93/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.5%
90/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
7.3%
101/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.0%
97/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
6.7%
92/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.0%
97/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
5.9%
81/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Nervous system disorders
Headache
|
7.8%
109/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
8.1%
112/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Psychiatric disorders
Insomnia
|
4.9%
68/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
5.6%
77/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
120/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
9.1%
125/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.3%
102/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
7.2%
99/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
83/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
5.0%
69/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Hypotension
|
8.3%
115/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
7.9%
109/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
|
Vascular disorders
Hypertension
|
7.3%
102/1389
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
6.7%
92/1378
The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place