|
All Individual Subject Deaths, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 09
|
table, FDA, safety, adverse events
|
|
Deaths, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 08
|
table, FDA, safety, deaths
|
|
Demographics and Baseline Clinical Characteristics, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 02
|
table, FDA, safety, demographics
|
|
Duration of Treatment Exposure, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 06
|
table, FDA, safety, exposure
|
|
Laboratory Test Results and Change from Baseline by Visit
|
Roche LBT01
|
table, Roche, parallel-group, change from baseline
|
|
Overview of Adverse Events by Demographic Subgroup, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 51
|
table, FDA, safety, adverse events
|
|
Overview of Adverse Events, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 07
|
table, FDA, safety, adverse events
|
|
Overview of Serious Adverse Events by Demographic Subgroup, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 50
|
table, FDA, safety, adverse events
|
|
Subject Populations, Randomized Population, Pooled Analysis (or Trial X)
|
FDA Table 04
|
table, FDA, safety, disposition
|
|
Subject Screening and Enrollment, Screening Population, Trials A and B
|
FDA Table 03
|
table, FDA, safety, disposition
|
|
Subjects Meeting Specific Postbaseline Hypotension Levels, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 38
|
table, FDA, safety, vital signs
|
|
Subjects With Adverse Events Leading to Treatment Discontinuation by Organ System and OCMQ (Narrow), Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 13
|
table, FDA, safety, adverse events
|
|
Subjects With Adverse Events Leading to Treatment Discontinuation by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 12
|
table, FDA, safety, adverse events
|
|
Subjects With Adverse Events by Female-Specific OCMQ (Broad) and Preferred Term, Female Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 45
|
table, FDA, safety, adverse events
|
|
Subjects With Adverse Events by Female-Specific OCMQ (Narrow) and Preferred Term, Female Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 34
|
table, FDA, safety, adverse events
|
|
Subjects With Adverse Events by Male-Specific OCMQ (Broad) and Preferred Term, Male Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 44
|
table, FDA, safety, adverse events
|
|
Subjects With Adverse Events by Male-Specific OCMQ (Narrow) and Preferred Term, Male Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 33
|
table, FDA, safety, adverse events
|
|
Subjects With Adverse Events by Organ System and OCMQ, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 17
|
table, FDA, safety, adverse events
|
|
Subjects With Adverse Events by Organ System, OCMQ (Broad) and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 43
|
table, FDA, safety, adverse events
|
|
Subjects With Adverse Events by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 14
|
table, FDA, safety, adverse events
|
|
Subjects With Common Adverse Events Occurring at ≥X% Frequency by Preferred Term, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 15
|
table, FDA, safety, adverse events
|
|
Subjects With Maximum Postbaseline Diastolic Blood Pressure by Category of Blood Pressure, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 37
|
table, FDA, safety, vital signs
|
|
Subjects With Maximum Postbaseline Systolic Blood Pressure by Category of Blood Pressure, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 36
|
table, FDA, safety, vital signs
|
|
Subjects With Serious Adverse Events by Organ System and OCMQ (Narrow), Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 11
|
table, FDA, safety, adverse events
|
|
Subjects With Serious Adverse Events by Organ System, OCMQ (Narrow) and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 29
|
table, FDA, safety, adverse events
|
|
Subjects With Serious Adverse Events by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 10
|
table, FDA, safety, adverse events
|
|
Summary Assessment of [Insert AE of Interest], Safety Population, Pooled Analysis (or Trial X)
|
FDA Table 18
|
table, FDA, safety, adverse events
|