Trial Outcomes & Findings for Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes (NCT NCT00136916)
NCT ID: NCT00136916
Last Updated: 2010-02-18
Results Overview
Change from Month 3: mean of (value of observed FEV1 \[forced expiratory volume in the first second of forced exhalation\] in liters \[L\] at treatment observation minus Month 3 value).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
635 participants
Primary outcome timeframe
Month 3 through extension Month 60
Results posted on
2010-02-18
Participant Flow
At screening visit and during the 4-week run-in phase subjects received subcutaneous insulin regime of 2 to 3 daily doses (QD) of regular insulin-/short-acting insulin analog (lispro or aspart) and 1 or 2 doses QD of intermediate or long-acting insulin (neutral protamine hagedorn \[NPH\] insulin or Ultralente®) or insulin glargine QD at bedtime.
Participant milestones
| Measure |
Inhaled Insulin (Exubera®)
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Overall Study
STARTED
|
319
|
316
|
|
Overall Study
Received Treatment
|
316
|
311
|
|
Overall Study
COMPLETED
|
194
|
212
|
|
Overall Study
NOT COMPLETED
|
125
|
104
|
Reasons for withdrawal
| Measure |
Inhaled Insulin (Exubera®)
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Overall Study
Never received study treatment
|
3
|
5
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Adverse Event
|
27
|
8
|
|
Overall Study
Laboratory abnormality
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
13
|
3
|
|
Overall Study
Lost to Follow-up
|
12
|
14
|
|
Overall Study
Withdrawal by Subject
|
44
|
46
|
|
Overall Study
Other
|
22
|
24
|
|
Overall Study
Discontinued in follow up period
|
3
|
0
|
Baseline Characteristics
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Inhaled Insulin (Exubera®)
n=316 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=311 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
Total
n=627 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 26 and 35 years
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Customized
Between 36 and 45 years
|
36 participants
n=5 Participants
|
49 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Age, Customized
Between 46 and 55 years
|
100 participants
n=5 Participants
|
93 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Age, Customized
Between 56 and 65 years
|
117 participants
n=5 Participants
|
101 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
Age, Customized
Between 66 and 75 years
|
61 participants
n=5 Participants
|
61 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Age Continuous
|
56.7 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3 through extension Month 60Population: Full analysis set (FAS) FEV1: received at least 1 dose treatment, had baseline and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.
Change from Month 3: mean of (value of observed FEV1 \[forced expiratory volume in the first second of forced exhalation\] in liters \[L\] at treatment observation minus Month 3 value).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline through extension follow up Month 3Population: FAS FEV1; extension Month 36 (M36) Last Observation Carried Forward (LOCF) based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure: change from Month 3 in forced expiratory volume in 1 second.
Change from baseline: mean of (value of observed FEV1 \[L\] at treatment observation minus baseline value).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=311 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=304 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Change From Baseline in FEV1
Baseline (n=311, 304)
|
2.91 L
Standard Deviation 0.68
|
2.93 L
Standard Deviation 0.71
|
|
Change From Baseline in FEV1
Month 3 (M3) (n=290, 291)
|
-0.06 L
Standard Deviation 0.13
|
-0.01 L
Standard Deviation 0.15
|
|
Change From Baseline in FEV1
M6 (n=281, 280)
|
-0.05 L
Standard Deviation 0.16
|
-0.05 L
Standard Deviation 0.17
|
|
Change From Baseline in FEV1
M9 (n=266, 276)
|
-0.08 L
Standard Deviation 0.17
|
-0.07 L
Standard Deviation 0.16
|
|
Change From Baseline in FEV1
Ext M9 (n=144, 157)
|
-0.19 L
Standard Deviation 0.21
|
-0.16 L
Standard Deviation 0.21
|
|
Change From Baseline in FEV1
Ext M12 (n=144, 157)
|
-0.20 L
Standard Deviation 0.21
|
-0.18 L
Standard Deviation 0.22
|
|
Change From Baseline in FEV1
Ext M27 (n=124, 125)
|
-0.25 L
Standard Deviation 0.23
|
-0.24 L
Standard Deviation 0.22
|
|
Change From Baseline in FEV1
Ext M30 (n=125, 126)
|
-0.24 L
Standard Deviation 0.22
|
-0.23 L
Standard Deviation 0.23
|
|
Change From Baseline in FEV1
Ext FU M3 (n=119, 115)
|
-0.24 L
Standard Deviation 0.21
|
-0.25 L
Standard Deviation 0.20
|
|
Change From Baseline in FEV1
M12 (n=259, 263)
|
-0.09 L
Standard Deviation 0.17
|
-0.07 L
Standard Deviation 0.16
|
|
Change From Baseline in FEV1
M15 (n=247, 250)
|
-0.12 L
Standard Deviation 0.18
|
-0.09 L
Standard Deviation 0.17
|
|
Change From Baseline in FEV1
M18 (n=237, 236)
|
-0.12 L
Standard Deviation 0.18
|
-0.10 L
Standard Deviation 0.18
|
|
Change From Baseline in FEV1
M21 (n=232, 233)
|
-0.13 L
Standard Deviation 0.18
|
-0.11 L
Standard Deviation 0.18
|
|
Change From Baseline in FEV1
M24 (n=223, 226)
|
-0.15 L
Standard Deviation 0.19
|
-0.13 L
Standard Deviation 0.18
|
|
Change From Baseline in FEV1
Follow-up (FU) M1 (n=249, 221)
|
-0.14 L
Standard Deviation 0.18
|
-0.14 L
Standard Deviation 0.19
|
|
Change From Baseline in FEV1
FU M3 (n=248, 231)
|
-0.13 L
Standard Deviation 0.21
|
-0.14 L
Standard Deviation 0.20
|
|
Change From Baseline in FEV1
FU M6 (n=242, 220)
|
-0.12 L
Standard Deviation 0.20
|
-0.15 L
Standard Deviation 0.18
|
|
Change From Baseline in FEV1
Extension (Ext) M1 (n=161, 163)
|
-0.16 L
Standard Deviation 0.20
|
-0.16 L
Standard Deviation 0.20
|
|
Change From Baseline in FEV1
Ext M3 (n=157, 158)
|
-0.19 L
Standard Deviation 0.21
|
-0.16 L
Standard Deviation 0.19
|
|
Change From Baseline in FEV1
Ext M6 (n=148, 159)
|
-0.20 L
Standard Deviation 0.21
|
-0.17 L
Standard Deviation 0.20
|
|
Change From Baseline in FEV1
Ext M15 (n=141, 145)
|
-0.22 L
Standard Deviation 0.23
|
-0.21 L
Standard Deviation 0.20
|
|
Change From Baseline in FEV1
Ext M18 (n=135, 139)
|
-0.22 L
Standard Deviation 0.23
|
-0.21 L
Standard Deviation 0.22
|
|
Change From Baseline in FEV1
Ext M21 (n=132, 143)
|
-0.23 L
Standard Deviation 0.24
|
-0.21 L
Standard Deviation 0.21
|
|
Change From Baseline in FEV1
Ext M24 (n=125, 131)
|
-0.24 L
Standard Deviation 0.24
|
-0.23 L
Standard Deviation 0.22
|
|
Change From Baseline in FEV1
Ext M33 (n=98, 113)
|
-0.24 L
Standard Deviation 0.24
|
-0.24 L
Standard Deviation 0.22
|
|
Change From Baseline in FEV1
Ext M36 (n=54, 60)
|
-0.25 L
Standard Deviation 0.18
|
-0.28 L
Standard Deviation 0.17
|
|
Change From Baseline in FEV1
Ext M36 [LOCF] (n=171, 169)
|
-0.24 L
Standard Deviation 0.24
|
-0.24 L
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Week -2 through extension follow up Month 3 or end of studyPopulation: FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in FEV1 were not summarized as planned.
Annual rate of change in FEV1 calculated as slope over time \[visit\] for forced expiratory volume in 1 second measured as liters per year (L/yr).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Month 3 through extension follow up Month 3Population: FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % \[(baseline observed value - visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=311 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=304 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Summary of ≥ 15 % Decliners in FEV1
FU M6 (n=242, 220)
|
13 participants
|
11 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M1 (n=161, 163)
|
12 participants
|
6 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M30 (n=125, 126)
|
20 participants
|
18 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M33 (n=98, 113)
|
10 participants
|
12 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M36 (n=54, 60)
|
5 participants
|
6 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext FU M3 (n=119, 115)
|
14 participants
|
19 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
M3 (n=290, 291)
|
2 participants
|
2 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
M6 (n=281, 280)
|
3 participants
|
4 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
M9 (n=266, 276)
|
7 participants
|
5 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
M12 (n=259, 263)
|
7 participants
|
4 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
M15 (n=247, 250)
|
13 participants
|
6 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
M18 (n=237, 236)
|
10 participants
|
8 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
M21 (n=232, 233)
|
12 participants
|
8 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
M24 (n=223, 226)
|
14 participants
|
13 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
FU M1 (n=249, 221)
|
11 participants
|
7 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
FU M3 (n=248, 231)
|
16 participants
|
15 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M3 (n=157, 158)
|
12 participants
|
5 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M6 (n=148, 159)
|
14 participants
|
8 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M9 (n=144, 157)
|
11 participants
|
10 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M12 (n=144, 157)
|
19 participants
|
13 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M15 (n=141, 145)
|
15 participants
|
11 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M18 (n=135, 139)
|
17 participants
|
18 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M21 (n=132, 143)
|
22 participants
|
11 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M24 (n=125, 131)
|
22 participants
|
16 participants
|
|
Summary of ≥ 15 % Decliners in FEV1
Ext M27 (n=124, 125)
|
18 participants
|
14 participants
|
PRIMARY outcome
Timeframe: Week -2 through extension follow up Month 3 or end of studyPopulation: FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in DLco were not summarized as planned. Cross reference outcome measure: change from baseline in Carbon Monoxide Diffusion Capacity (DLco).
Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline through extension follow up Month 3Population: FAS FEV1; extension M36 LOCF based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure Annual rate of change in Carbon Monoxide Diffusion Capacity (DLco).
Change from baseline: mean of (value of observed DLco \[milliliters per minute per millimeters of mercury (ml/min/mmHg)\] at treatment observation minus baseline value).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=308 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext FU M3 (n=118, 114)
|
-1.12 ml/min/mmHg
Standard Deviation 2.15
|
-1.69 ml/min/mmHg
Standard Deviation 2.56
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
M6 (n=278, 280)
|
-0.56 ml/min/mmHg
Standard Deviation 1.62
|
-0.44 ml/min/mmHg
Standard Deviation 1.73
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
M24 (n=221, 223)
|
-0.74 ml/min/mmHg
Standard Deviation 2.10
|
-0.81 ml/min/mmHg
Standard Deviation 2.06
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
FU M1 (n=247, 220)
|
-0.46 ml/min/mmHg
Standard Deviation 2.05
|
-1.02 ml/min/mmHg
Standard Deviation 2.01
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M12 (n=141, 155)
|
-1.49 ml/min/mmHg
Standard Deviation 2.22
|
-1.59 ml/min/mmHg
Standard Deviation 2.38
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M15 (n=141, 142)
|
-1.49 ml/min/mmHg
Standard Deviation 2.25
|
-1.46 ml/min/mmHg
Standard Deviation 2.41
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M21 (n=129, 142)
|
-1.33 ml/min/mmHg
Standard Deviation 2.45
|
-1.64 ml/min/mmHg
Standard Deviation 2.45
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M24 (n=124, 130)
|
-1.39 ml/min/mmHg
Standard Deviation 2.27
|
-1.46 ml/min/mmHg
Standard Deviation 2.43
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Baseline (n=308, 303)
|
24.13 ml/min/mmHg
Standard Deviation 5.54
|
23.97 ml/min/mmHg
Standard Deviation 5.72
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
M3 (n=289, 290)
|
-0.57 ml/min/mmHg
Standard Deviation 1.60
|
-0.32 ml/min/mmHg
Standard Deviation 1.62
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
M9 (n=266, 272)
|
-0.67 ml/min/mmHg
Standard Deviation 1.78
|
-0.72 ml/min/mmHg
Standard Deviation 1.77
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
M12 (n=258, 263)
|
-0.72 ml/min/mmHg
Standard Deviation 1.86
|
-0.41 ml/min/mmHg
Standard Deviation 1.87
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
M15 (n=246, 248)
|
-0.81 ml/min/mmHg
Standard Deviation 1.83
|
-0.56 ml/min/mmHg
Standard Deviation 1.96
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
M18 (n=237, 232)
|
-0.86 ml/min/mmHg
Standard Deviation 1.95
|
-0.65 ml/min/mmHg
Standard Deviation 1.92
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
M21 (n=231, 231)
|
-0.89 ml/min/mmHg
Standard Deviation 1.98
|
-0.67 ml/min/mmHg
Standard Deviation 1.92
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
FU M3 (n=247, 231)
|
-0.58 ml/min/mmHg
Standard Deviation 2.07
|
-0.90 ml/min/mmHg
Standard Deviation 2.15
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
FU M6 (n=241, 219)
|
-0.64 ml/min/mmHg
Standard Deviation 2.15
|
-0.95 ml/min/mmHg
Standard Deviation 2.11
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M1 (n=159, 161)
|
-1.01 ml/min/mmHg
Standard Deviation 2.08
|
-1.09 ml/min/mmHg
Standard Deviation 2.15
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M3 (n=157, 157)
|
-1.07 ml/min/mmHg
Standard Deviation 2.10
|
-1.16 ml/min/mmHg
Standard Deviation 2.45
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M6 (n=148, 157)
|
-1.48 ml/min/mmHg
Standard Deviation 1.87
|
-1.26 ml/min/mmHg
Standard Deviation 2.38
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M9 (n=143, 155)
|
-1.15 ml/min/mmHg
Standard Deviation 2.31
|
-1.36 ml/min/mmHg
Standard Deviation 2.54
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M18 (n=132, 138)
|
-1.54 ml/min/mmHg
Standard Deviation 2.25
|
-1.63 ml/min/mmHg
Standard Deviation 2.21
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M27 (n=123, 124)
|
-1.35 ml/min/mmHg
Standard Deviation 2.48
|
-1.44 ml/min/mmHg
Standard Deviation 2.41
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M30 (n=124, 125)
|
-1.75 ml/min/mmHg
Standard Deviation 2.13
|
-1.62 ml/min/mmHg
Standard Deviation 2.55
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M33 (n=98, 113)
|
-1.47 ml/min/mmHg
Standard Deviation 2.05
|
-1.61 ml/min/mmHg
Standard Deviation 2.25
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M36 (n=52, 60)
|
-1.22 ml/min/mmHg
Standard Deviation 2.16
|
-1.87 ml/min/mmHg
Standard Deviation 2.23
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ext M36 [LOCF] (n=171, 169)
|
-1.39 ml/min/mmHg
Standard Deviation 2.31
|
-1.77 ml/min/mmHg
Standard Deviation 2.46
|
PRIMARY outcome
Timeframe: Month 3 through extension follow up Month 3Population: FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Number of subjects with a post-baseline DLco decrease of ≥ 20 % \[(baseline observed value - visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=308 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Summary of ≥ 20 % Decliners in DLco
M3 (n=289, 290)
|
0 participants
|
2 participants
|
|
Summary of ≥ 20 % Decliners in DLco
M6 (n=278, 280)
|
1 participants
|
2 participants
|
|
Summary of ≥ 20 % Decliners in DLco
M9 (n=266, 272)
|
0 participants
|
3 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M36 (n=52, 60)
|
2 participants
|
3 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext FU M3 (n=118, 114)
|
6 participants
|
10 participants
|
|
Summary of ≥ 20 % Decliners in DLco
M12 (n=258, 263)
|
4 participants
|
3 participants
|
|
Summary of ≥ 20 % Decliners in DLco
M15 (n=246, 248)
|
1 participants
|
2 participants
|
|
Summary of ≥ 20 % Decliners in DLco
M18(n=237, 232)
|
2 participants
|
5 participants
|
|
Summary of ≥ 20 % Decliners in DLco
M21 (n=231, 231)
|
0 participants
|
3 participants
|
|
Summary of ≥ 20 % Decliners in DLco
M24 (n=221, 223)
|
4 participants
|
5 participants
|
|
Summary of ≥ 20 % Decliners in DLco
FU M1 (n=247, 220)
|
2 participants
|
4 participants
|
|
Summary of ≥ 20 % Decliners in DLco
FU M3 (n=247, 231)
|
3 participants
|
6 participants
|
|
Summary of ≥ 20 % Decliners in DLco
FU M6 (n=241, 219)
|
5 participants
|
5 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M1 (n=159, 161)
|
3 participants
|
3 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M3 (n=157, 157)
|
3 participants
|
8 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M6 (n=148, 157)
|
4 participants
|
6 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M9 (n=143, 155)
|
4 participants
|
7 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M12 (n=141, 155)
|
8 participants
|
9 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M15(n=141, 142)
|
4 participants
|
6 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M18 (n=132, 138)
|
6 participants
|
7 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M21(n=129, 142)
|
4 participants
|
8 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M24 (n=124, 130)
|
5 participants
|
7 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M27(n=123, 124)
|
7 participants
|
8 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M30 (n=124, 125)
|
7 participants
|
11 participants
|
|
Summary of ≥ 20 % Decliners in DLco
Ext M33(n=98, 113)
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Week -3 through extension follow up Month 3 or end of studyPopulation: FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of FVC were not summarized as planned.
Forced Vital Capacity (FVC) measured in liters (L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through extension follow up Month 3Population: FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TLC were not summarized as planned.
Total Lung Capacity measured in liters (L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through extension follow up Month 3Population: FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Change from baseline: mean of (value of observed HbA1c \[%\] at treatment observation minus baseline value).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=315 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
M9 (n=270, 280)
|
-0.56 percent
Standard Deviation 0.98
|
-0.61 percent
Standard Deviation 0.93
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
M12 (n=261, 263)
|
-0.45 percent
Standard Deviation 0.94
|
-0.58 percent
Standard Deviation 1.00
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
M15(n=252, 258)
|
-0.43 percent
Standard Deviation 1.00
|
-0.51 percent
Standard Deviation 1.00
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M15(n=146, 151)
|
-0.17 percent
Standard Deviation 1.30
|
-0.25 percent
Standard Deviation 1.15
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M18 (n=145, 145)
|
-0.20 percent
Standard Deviation 1.19
|
-0.29 percent
Standard Deviation 1.17
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline (n=315, 303)
|
7.66 percent
Standard Deviation 1.12
|
7.77 percent
Standard Deviation 1.12
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Week 6 (W6) (n=291, 280)
|
-0.64 percent
Standard Deviation 0.67
|
-0.60 percent
Standard Deviation 0.70
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
M3 (n=296, 291)
|
-0.80 percent
Standard Deviation 0.86
|
-0.73 percent
Standard Deviation 0.89
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
M6 (n=284, 287)
|
-0.67 percent
Standard Deviation 0.94
|
-0.68 percent
Standard Deviation 1.00
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
M18(n=244, 241)
|
-0.42 percent
Standard Deviation 1.02
|
-0.53 percent
Standard Deviation 1.06
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
M21 (n=236, 238)
|
-0.43 percent
Standard Deviation 1.04
|
-0.52 percent
Standard Deviation 1.02
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
M24 (n=226, 234)
|
-0.35 percent
Standard Deviation 1.09
|
-0.48 percent
Standard Deviation 1.13
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
FU M3 (n=225, 226)
|
-0.41 percent
Standard Deviation 1.04
|
-0.44 percent
Standard Deviation 1.06
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
FU M6 (n=230, 230)
|
-0.27 percent
Standard Deviation 1.12
|
-0.31 percent
Standard Deviation 1.06
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M1 (n=167, 162)
|
-0.41 percent
Standard Deviation 1.16
|
-0.40 percent
Standard Deviation 1.05
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M3 (n=164, 162)
|
-0.33 percent
Standard Deviation 1.19
|
-0.42 percent
Standard Deviation 1.05
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M6 (n=157, 163)
|
-0.26 percent
Standard Deviation 1.11
|
-0.40 percent
Standard Deviation 1.10
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M9 (n=152, 157)
|
-0.11 percent
Standard Deviation 1.15
|
-0.26 percent
Standard Deviation 1.13
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M12 (n=150, 157)
|
-0.08 percent
Standard Deviation 1.19
|
-0.17 percent
Standard Deviation 1.16
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M21(n=137, 147)
|
-0.13 percent
Standard Deviation 1.16
|
-0.20 percent
Standard Deviation 1.20
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M24 (n=131, 137)
|
-0.18 percent
Standard Deviation 1.21
|
-0.23 percent
Standard Deviation 1.11
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M27(n=129, 132)
|
-0.18 percent
Standard Deviation 1.13
|
-0.28 percent
Standard Deviation 1.20
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M30 (n=129, 129)
|
-0.20 percent
Standard Deviation 1.19
|
-0.30 percent
Standard Deviation 1.19
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M33(n=104, 116)
|
8.54 percent
Standard Deviation 88.44
|
-0.18 percent
Standard Deviation 1.17
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext M36 (n=55, 64)
|
-0.20 percent
Standard Deviation 1.15
|
-0.30 percent
Standard Deviation 1.18
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ext FU M3 (n=117, 116)
|
-0.11 percent
Standard Deviation 1.40
|
-0.17 percent
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Baseline through extension follow up Month 3Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Change from baseline: mean of (value of observed FPG \[milligrams per deciliter (mg/dL)\] at treatment observation minus baseline value).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=315 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M1 (n=165, 162)
|
-17.91 mg/dL
Standard Deviation 60.96
|
-7.34 mg/dL
Standard Deviation 60.98
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M3 (n=162, 159)
|
-18.16 mg/dL
Standard Deviation 66.59
|
-9.29 mg/dL
Standard Deviation 62.50
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Baseline (n=315, 303)
|
158.13 mg/dL
Standard Deviation 42.71
|
154.53 mg/dL
Standard Deviation 41.51
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
W6 (n=282, 276)
|
-23.36 mg/dL
Standard Deviation 51.69
|
-12.55 mg/dL
Standard Deviation 50.46
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
M3 (n=294, 290)
|
-26.38 mg/dL
Standard Deviation 52.72
|
-12.77 mg/dL
Standard Deviation 54.93
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
M6 (n=281, 285)
|
-25.21 mg/dL
Standard Deviation 53.48
|
-9.05 mg/dL
Standard Deviation 68.42
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
M9 (n=267, 279)
|
-26.68 mg/dL
Standard Deviation 54.95
|
-10.41 mg/dL
Standard Deviation 56.42
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
M12 (n=260, 263)
|
-20.55 mg/dL
Standard Deviation 59.68
|
-7.60 mg/dL
Standard Deviation 60.03
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
M15(n=253, 255)
|
-21.37 mg/dL
Standard Deviation 54.53
|
-8.82 mg/dL
Standard Deviation 55.57
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
M18(n=242, 238)
|
-24.52 mg/dL
Standard Deviation 54.50
|
-7.69 mg/dL
Standard Deviation 58.47
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
M21(n=232, 237)
|
-25.95 mg/dL
Standard Deviation 53.06
|
-13.14 mg/dL
Standard Deviation 54.66
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
M24 (n=226, 232)
|
-24.02 mg/dL
Standard Deviation 54.45
|
-8.91 mg/dL
Standard Deviation 65.24
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
FU M3 (n=5, 4)
|
-22.60 mg/dL
Standard Deviation 44.65
|
-4.08 mg/dL
Standard Deviation 32.08
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
FU M6 (n=161, 156)
|
-2.85 mg/dL
Standard Deviation 66.18
|
-1.56 mg/dL
Standard Deviation 71.72
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M6 (n=152, 161)
|
-15.65 mg/dL
Standard Deviation 67.18
|
-4.34 mg/dL
Standard Deviation 61.96
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M9 (n=149, 155)
|
-13.99 mg/dL
Standard Deviation 61.68
|
-6.06 mg/dL
Standard Deviation 60.86
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M12 (n=148, 155)
|
-12.53 mg/dL
Standard Deviation 72.25
|
-4.98 mg/dL
Standard Deviation 62.92
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M15(n=143, 143)
|
-6.88 mg/dL
Standard Deviation 68.85
|
-4.23 mg/dL
Standard Deviation 65.21
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M18 (n=136, 138)
|
-17.23 mg/dL
Standard Deviation 65.97
|
-10.32 mg/dL
Standard Deviation 63.11
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M21(n=132, 144)
|
-12.86 mg/dL
Standard Deviation 63.98
|
-6.53 mg/dL
Standard Deviation 64.09
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M24 (n=129, 136)
|
-14.45 mg/dL
Standard Deviation 61.65
|
-3.47 mg/dL
Standard Deviation 68.57
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M27 (n=128, 129)
|
-21.68 mg/dL
Standard Deviation 58.35
|
-3.76 mg/dL
Standard Deviation 63.31
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M30 (n=127, 130)
|
-11.80 mg/dL
Standard Deviation 62.82
|
-6.40 mg/dL
Standard Deviation 61.47
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M33(n=103, 115)
|
-16.26 mg/dL
Standard Deviation 63.44
|
-7.35 mg/dL
Standard Deviation 66.21
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext M36 (n=55, 64)
|
-28.61 mg/dL
Standard Deviation 65.99
|
-13.35 mg/dL
Standard Deviation 53.97
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Ext FU M3 (n=115, 118)
|
-2.87 mg/dL
Standard Deviation 81.19
|
1.88 mg/dL
Standard Deviation 64.94
|
SECONDARY outcome
Timeframe: Baseline through extension follow up Month 3Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Change from baseline: mean of (value of observed body weight \[kilograms (kg)\] at treatment observation minus baseline value).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=314 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=302 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Change From Baseline in Body Weight
W4 (n=280, 270)
|
0.63 kg
Standard Deviation 2.11
|
0.83 kg
Standard Deviation 1.86
|
|
Change From Baseline in Body Weight
W8 (n=289, 281)
|
1.07 kg
Standard Deviation 2.41
|
1.00 kg
Standard Deviation 2.31
|
|
Change From Baseline in Body Weight
M3 (n=288, 290)
|
1.08 kg
Standard Deviation 2.75
|
1.13 kg
Standard Deviation 2.55
|
|
Change From Baseline in Body Weight
Baseline (n=314, 302)
|
87.18 kg
Standard Deviation 14.75
|
88.31 kg
Standard Deviation 15.50
|
|
Change From Baseline in Body Weight
W18(n=280, 285)
|
1.33 kg
Standard Deviation 3.13
|
1.76 kg
Standard Deviation 3.03
|
|
Change From Baseline in Body Weight
M6 (n=276, 277)
|
1.15 kg
Standard Deviation 3.59
|
1.89 kg
Standard Deviation 3.53
|
|
Change From Baseline in Body Weight
M9 (n=269, 274)
|
1.50 kg
Standard Deviation 3.95
|
2.15 kg
Standard Deviation 3.90
|
|
Change From Baseline in Body Weight
M12 (n=259, 264)
|
1.75 kg
Standard Deviation 4.29
|
2.37 kg
Standard Deviation 4.34
|
|
Change From Baseline in Body Weight
M15(n=247, 249)
|
1.88 kg
Standard Deviation 4.33
|
2.62 kg
Standard Deviation 4.49
|
|
Change From Baseline in Body Weight
M18(n=237, 235)
|
1.79 kg
Standard Deviation 4.53
|
2.93 kg
Standard Deviation 4.85
|
|
Change From Baseline in Body Weight
M21(n=232, 232)
|
1.99 kg
Standard Deviation 4.56
|
3.04 kg
Standard Deviation 5.04
|
|
Change From Baseline in Body Weight
M24 (n=223, 226)
|
2.04 kg
Standard Deviation 4.86
|
3.36 kg
Standard Deviation 5.16
|
|
Change From Baseline in Body Weight
FU M3 (n=249, 231)
|
2.32 kg
Standard Deviation 5.25
|
3.63 kg
Standard Deviation 5.34
|
|
Change From Baseline in Body Weight
FU M6 (n=243, 218)
|
2.38 kg
Standard Deviation 5.34
|
4.09 kg
Standard Deviation 7.70
|
|
Change From Baseline in Body Weight
Ext M1 (n=161, 162)
|
2.87 kg
Standard Deviation 5.48
|
3.75 kg
Standard Deviation 5.58
|
|
Change From Baseline in Body Weight
Ext M3 (n=157, 157)
|
2.83 kg
Standard Deviation 4.78
|
4.14 kg
Standard Deviation 5.69
|
|
Change From Baseline in Body Weight
Ext M6 (n=148, 159)
|
3.15 kg
Standard Deviation 5.70
|
4.01 kg
Standard Deviation 6.07
|
|
Change From Baseline in Body Weight
Ext M9 (n=144, 156)
|
2.95 kg
Standard Deviation 5.95
|
3.89 kg
Standard Deviation 5.87
|
|
Change From Baseline in Body Weight
Ext M12 (n=144, 156)
|
2.96 kg
Standard Deviation 6.00
|
4.19 kg
Standard Deviation 6.12
|
|
Change From Baseline in Body Weight
Ext M15 (n=142, 145)
|
3.12 kg
Standard Deviation 5.91
|
4.54 kg
Standard Deviation 6.26
|
|
Change From Baseline in Body Weight
Ext M18 (n=135, 139)
|
3.33 kg
Standard Deviation 9.20
|
4.46 kg
Standard Deviation 6.12
|
|
Change From Baseline in Body Weight
Ext M21(n=132, 143)
|
2.79 kg
Standard Deviation 6.90
|
5.01 kg
Standard Deviation 8.37
|
|
Change From Baseline in Body Weight
Ext M24 (n=126, 131)
|
2.94 kg
Standard Deviation 6.98
|
4.57 kg
Standard Deviation 6.37
|
|
Change From Baseline in Body Weight
Ext M27(n=125, 125)
|
2.99 kg
Standard Deviation 6.94
|
5.58 kg
Standard Deviation 9.62
|
|
Change From Baseline in Body Weight
Ext M30 (n=125, 126)
|
3.39 kg
Standard Deviation 6.43
|
4.78 kg
Standard Deviation 6.96
|
|
Change From Baseline in Body Weight
Ext M33(n=99, 113)
|
2.77 kg
Standard Deviation 6.33
|
5.22 kg
Standard Deviation 7.21
|
|
Change From Baseline in Body Weight
Ext M36 (n=54, 60)
|
2.48 kg
Standard Deviation 6.61
|
5.28 kg
Standard Deviation 7.09
|
|
Change From Baseline in Body Weight
Ext FU M3 (n=119, 115)
|
2.74 kg
Standard Deviation 6.90
|
4.44 kg
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Month 3 through extension Month 36Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=315 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M21 (n=137, 148)
|
46.49 units
Standard Deviation 31.17
|
52.68 units
Standard Deviation 29.40
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M30 (n=131, 130)
|
48.13 units
Standard Deviation 33.41
|
53.22 units
Standard Deviation 29.85
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
M3 (n=301, 298)
|
44.10 units
Standard Deviation 25.60
|
47.98 units
Standard Deviation 25.06
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
M6 (n=289, 291)
|
44.03 units
Standard Deviation 26.27
|
47.31 units
Standard Deviation 25.47
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
M9 (n=275, 284)
|
43.64 units
Standard Deviation 26.17
|
48.11 units
Standard Deviation 26.02
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
M12 (n=266, 270)
|
44.62 units
Standard Deviation 27.43
|
48.01 units
Standard Deviation 26.02
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
M15 (n=258, 260)
|
45.02 units
Standard Deviation 27.76
|
48.37 units
Standard Deviation 26.48
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
M18 (n=243, 242)
|
46.07 units
Standard Deviation 27.77
|
48.93 units
Standard Deviation 27.60
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
M21 (n=240, 240)
|
46.67 units
Standard Deviation 29.06
|
49.84 units
Standard Deviation 28.73
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
M24 (n=229, 237)
|
46.62 units
Standard Deviation 28.55
|
50.34 units
Standard Deviation 29.31
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M1 (n=167, 164)
|
45.29 units
Standard Deviation 28.00
|
51.29 units
Standard Deviation 28.45
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M3 (n=165, 162)
|
45.76 units
Standard Deviation 28.61
|
51.62 units
Standard Deviation 28.71
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M6 (n=159, 164)
|
45.89 units
Standard Deviation 28.61
|
52.18 units
Standard Deviation 28.85
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M9 (n=156, 158)
|
46.51 units
Standard Deviation 29.34
|
52.32 units
Standard Deviation 28.89
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M12 (n=151, 158)
|
46.52 units
Standard Deviation 29.84
|
51.72 units
Standard Deviation 29.06
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M15 (n=148, 149)
|
46.39 units
Standard Deviation 30.12
|
52.92 units
Standard Deviation 29.83
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M18 (n=145, 145)
|
46.31 units
Standard Deviation 31.17
|
52.37 units
Standard Deviation 29.78
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M24 (n=131, 137)
|
47.21 units
Standard Deviation 32.42
|
52.18 units
Standard Deviation 30.33
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M27 (n=132, 133)
|
48.13 units
Standard Deviation 32.76
|
52.42 units
Standard Deviation 29.87
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M33 (n=104, 116)
|
48.38 units
Standard Deviation 32.47
|
51.93 units
Standard Deviation 30.65
|
|
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Ext M36 (n=56, 65)
|
46.42 units
Standard Deviation 31.91
|
53.47 units
Standard Deviation 28.96
|
SECONDARY outcome
Timeframe: Month 3 through extension Month 36Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Total daily dose of long-acting insulin adjusted for body weight (units per kilogram \[kg\]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=315 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
M18 (n=243, 242)
|
0.53 units/kg
Standard Deviation 0.31
|
0.57 units/kg
Standard Deviation 0.31
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
M21 (n=240, 240)
|
0.53 units/kg
Standard Deviation 0.32
|
0.57 units/kg
Standard Deviation 0.32
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M27 (n=132, 133)
|
0.56 units/kg
Standard Deviation 0.39
|
0.61 units/kg
Standard Deviation 0.33
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M30 (n=131, 130)
|
0.56 units/kg
Standard Deviation 0.41
|
0.62 units/kg
Standard Deviation 0.33
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M33 (n=104, 116)
|
0.56 units/kg
Standard Deviation 0.37
|
0.61 units/kg
Standard Deviation 0.34
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M36 (n=56, 65)
|
0.53 units/kg
Standard Deviation 0.37
|
0.61 units/kg
Standard Deviation 0.31
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
M3 (n=301, 298)
|
0.51 units/kg
Standard Deviation 0.29
|
0.54 units/kg
Standard Deviation 0.27
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
M6 (n=289, 291)
|
0.50 units/kg
Standard Deviation 0.29
|
0.54 units/kg
Standard Deviation 0.28
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
M9 (n=275, 284)
|
0.50 units/kg
Standard Deviation 0.29
|
0.55 units/kg
Standard Deviation 0.29
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
M12 (n=266, 270)
|
0.51 units/kg
Standard Deviation 0.30
|
0.55 units/kg
Standard Deviation 0.29
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
M15 (n=258, 260)
|
0.52 units/kg
Standard Deviation 0.31
|
0.56 units/kg
Standard Deviation 0.30
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
M24 (n=229, 237)
|
0.54 units/kg
Standard Deviation 0.32
|
0.58 units/kg
Standard Deviation 0.32
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M1 (n=167, 164)
|
0.53 units/kg
Standard Deviation 0.33
|
0.59 units/kg
Standard Deviation 0.31
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M3 (n=165, 162)
|
0.53 units/kg
Standard Deviation 0.34
|
0.59 units/kg
Standard Deviation 0.31
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M6 (n=159, 164)
|
0.54 units/kg
Standard Deviation 0.34
|
0.60 units/kg
Standard Deviation 0.31
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M9 (n=156, 158)
|
0.54 units/kg
Standard Deviation 0.35
|
0.60 units/kg
Standard Deviation 0.31
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M12 (n=151, 158)
|
0.54 units/kg
Standard Deviation 0.36
|
0.60 units/kg
Standard Deviation 0.32
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M15 (n=148, 149)
|
0.54 units/kg
Standard Deviation 0.36
|
0.61 units/kg
Standard Deviation 0.32
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M18 (n=145, 145)
|
0.54 units/kg
Standard Deviation 0.37
|
0.61 units/kg
Standard Deviation 0.32
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M21 (n=137, 148)
|
0.54 units/kg
Standard Deviation 0.37
|
0.61 units/kg
Standard Deviation 0.32
|
|
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Ext M24 (n=131, 137)
|
0.55 units/kg
Standard Deviation 0.39
|
0.61 units/kg
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Month 3 through extension Month 36Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams \[mg\]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin.
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=315 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
M9 (n=275, 285)
|
13.57 mg, units
Standard Deviation 7.57
|
31.58 mg, units
Standard Deviation 18.89
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
M12 (n=266, 270)
|
14.40 mg, units
Standard Deviation 7.90
|
31.94 mg, units
Standard Deviation 19.29
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M6 (n=159, 165)
|
14.62 mg, units
Standard Deviation 9.16
|
35.43 mg, units
Standard Deviation 24.80
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M9 (n=156, 161)
|
14.82 mg, units
Standard Deviation 9.10
|
35.68 mg, units
Standard Deviation 24.72
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M12 (n=151, 160)
|
15.42 mg, units
Standard Deviation 9.81
|
36.56 mg, units
Standard Deviation 26.34
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M15 (n=148, 151)
|
15.48 mg, units
Standard Deviation 9.90
|
36.27 mg, units
Standard Deviation 25.51
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M18 (n=145, 146)
|
15.57 mg, units
Standard Deviation 9.93
|
37.37 mg, units
Standard Deviation 26.29
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M33 (n=105, 117)
|
16.51 mg, units
Standard Deviation 10.43
|
40.33 mg, units
Standard Deviation 30.81
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
M3 (n=302, 299)
|
12.66 mg, units
Standard Deviation 6.80
|
31.15 mg, units
Standard Deviation 18.75
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
M6 (n=290, 292)
|
13.18 mg, units
Standard Deviation 6.90
|
31.73 mg, units
Standard Deviation 19.08
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
M15 (n=258, 261)
|
14.70 mg, units
Standard Deviation 8.06
|
31.88 mg, units
Standard Deviation 19.37
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
M18 (n=245, 242)
|
14.91 mg, units
Standard Deviation 8.41
|
32.79 mg, units
Standard Deviation 20.70
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
M21 (n=240, 242)
|
15.09 mg, units
Standard Deviation 8.55
|
33.18 mg, units
Standard Deviation 20.92
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
M24 (n=229, 238)
|
15.43 mg, units
Standard Deviation 8.65
|
34.04 mg, units
Standard Deviation 21.84
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M21 (n=138, 149)
|
15.94 mg, units
Standard Deviation 10.41
|
36.80 mg, units
Standard Deviation 27.09
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M24 (n=131, 138)
|
15.46 mg, units
Standard Deviation 9.70
|
38.51 mg, units
Standard Deviation 29.06
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M27 (n=132, 134)
|
16.25 mg, units
Standard Deviation 10.30
|
38.54 mg, units
Standard Deviation 28.13
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M30 (n=131, 131)
|
16.56 mg, units
Standard Deviation 10.63
|
39.01 mg, units
Standard Deviation 28.66
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M36 (n=56, 66)
|
17.25 mg, units
Standard Deviation 11.30
|
42.34 mg, units
Standard Deviation 28.72
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M1 (n=167, 164)
|
13.89 mg, units
Standard Deviation 8.47
|
34.52 mg, units
Standard Deviation 24.52
|
|
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Ext M3 (n=165, 163)
|
14.62 mg, units
Standard Deviation 9.18
|
35.29 mg, units
Standard Deviation 23.19
|
SECONDARY outcome
Timeframe: Month 3 through extension Month 36Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=315 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
M12 (n=266, 270)
|
0.17 mg/kg, units/kg
Standard Deviation 0.09
|
0.37 mg/kg, units/kg
Standard Deviation 0.23
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
M15 (n=258, 261)
|
0.17 mg/kg, units/kg
Standard Deviation 0.09
|
0.37 mg/kg, units/kg
Standard Deviation 0.24
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
M21 (n=240, 242)
|
0.17 mg/kg, units/kg
Standard Deviation 0.09
|
0.39 mg/kg, units/kg
Standard Deviation 0.26
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
M24 (n=229, 238)
|
0.18 mg/kg, units/kg
Standard Deviation 0.10
|
0.40 mg/kg, units/kg
Standard Deviation 0.27
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M3 (n=165, 163)
|
0.17 mg/kg, units/kg
Standard Deviation 0.10
|
0.41 mg/kg, units/kg
Standard Deviation 0.26
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M6 (n=159, 165)
|
0.17 mg/kg, units/kg
Standard Deviation 0.10
|
0.41 mg/kg, units/kg
Standard Deviation 0.30
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M9 (n=156, 161)
|
0.17 mg/kg, units/kg
Standard Deviation 0.10
|
0.42 mg/kg, units/kg
Standard Deviation 0.30
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M15 (n=148, 151)
|
0.18 mg/kg, units/kg
Standard Deviation 0.11
|
0.42 mg/kg, units/kg
Standard Deviation 0.31
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M18 (n=145, 146)
|
0.18 mg/kg, units/kg
Standard Deviation 0.11
|
0.44 mg/kg, units/kg
Standard Deviation 0.32
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M24 (n=131, 138)
|
0.18 mg/kg, units/kg
Standard Deviation 0.10
|
0.45 mg/kg, units/kg
Standard Deviation 0.35
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
M3 (n=302, 299)
|
0.15 mg/kg, units/kg
Standard Deviation 0.07
|
0.36 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
M6 (n=290, 292)
|
0.15 mg/kg, units/kg
Standard Deviation 0.08
|
0.36 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
M9 (n=275, 285)
|
0.16 mg/kg, units/kg
Standard Deviation 0.08
|
0.36 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
M18 (n=245, 242)
|
0.17 mg/kg, units/kg
Standard Deviation 0.09
|
0.38 mg/kg, units/kg
Standard Deviation 0.25
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M1 (n=167, 164)
|
0.16 mg/kg, units/kg
Standard Deviation 0.09
|
0.40 mg/kg, units/kg
Standard Deviation 0.30
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M12 (n=151, 160)
|
0.18 mg/kg, units/kg
Standard Deviation 0.11
|
0.43 mg/kg, units/kg
Standard Deviation 0.32
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M21 (n=138, 149)
|
0.18 mg/kg, units/kg
Standard Deviation 0.11
|
0.43 mg/kg, units/kg
Standard Deviation 0.33
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M27 (n=132, 134)
|
0.19 mg/kg, units/kg
Standard Deviation 0.11
|
0.45 mg/kg, units/kg
Standard Deviation 0.34
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M30 (n=131, 131)
|
0.19 mg/kg, units/kg
Standard Deviation 0.12
|
0.46 mg/kg, units/kg
Standard Deviation 0.34
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M33 (n=105, 117)
|
0.19 mg/kg, units/kg
Standard Deviation 0.11
|
0.47 mg/kg, units/kg
Standard Deviation 0.36
|
|
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Ext M36 (n=56, 66)
|
0.19 mg/kg, units/kg
Standard Deviation 0.12
|
0.48 mg/kg, units/kg
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Week -4 through Month 24Population: FAS: received at least 1 dose of study treatment. Due to early termination of study a limited set of analyses were undertaken and results of Lipids were not summarized as planned.
Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 1 through extension Month 36Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=315 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Hypoglycemic Event Rates
M2 (n=307, 302)
|
1.40 event rate (events/subject months)
|
1.60 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M8 (n=276, 288)
|
0.82 event rate (events/subject months)
|
0.94 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M14 (n=260, 265)
|
0.62 event rate (events/subject months)
|
0.87 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M16 (n=254, 261)
|
0.68 event rate (events/subject months)
|
0.97 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M17 (n=252, 257)
|
0.53 event rate (events/subject months)
|
0.82 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M18 (n=246, 253)
|
0.61 event rate (events/subject months)
|
0.95 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M19 (n=245, 252)
|
0.59 event rate (events/subject months)
|
0.78 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M20 (n=242, 249)
|
0.62 event rate (events/subject months)
|
0.73 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M1 (n=315, 303)
|
1.63 event rate (events/subject months)
|
1.80 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M3 (n=297, 298)
|
1.22 event rate (events/subject months)
|
1.65 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M4 (n=289, 295)
|
1.10 event rate (events/subject months)
|
1.64 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M5 (n=284, 293)
|
0.95 event rate (events/subject months)
|
1.28 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M6 (n=283, 290)
|
0.98 event rate (events/subject months)
|
1.09 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M7 (n=280, 289)
|
0.80 event rate (events/subject months)
|
1.12 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M9 (n=275, 287)
|
0.71 event rate (events/subject months)
|
0.86 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M10 (n=273, 285)
|
0.72 event rate (events/subject months)
|
0.93 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M11 (n=267, 274)
|
0.68 event rate (events/subject months)
|
0.79 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M12 (n=264, 274)
|
0.72 event rate (events/subject months)
|
0.94 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M13 (n=263, 269)
|
0.71 event rate (events/subject months)
|
0.82 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M15 (n=256, 265)
|
0.64 event rate (events/subject months)
|
0.78 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M21 (n=241, 246)
|
0.57 event rate (events/subject months)
|
0.65 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M22 (n=236, 244)
|
0.44 event rate (events/subject months)
|
0.72 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M34 (n=84, 90)
|
0.64 event rate (events/subject months)
|
0.57 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M23 (n=236, 241)
|
0.41 event rate (events/subject months)
|
0.82 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
M24 (n=229, 232)
|
0.45 event rate (events/subject months)
|
0.66 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M35 (n=66, 78)
|
0.63 event rate (events/subject months)
|
0.80 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M1 (n=172, 169)
|
1.16 event rate (events/subject months)
|
1.16 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M2 (n=171, 169)
|
1.10 event rate (events/subject months)
|
1.33 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M3 (n=169, 169)
|
1.02 event rate (events/subject months)
|
1.12 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M4 (n=167, 169)
|
0.87 event rate (events/subject months)
|
1.44 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M5 (n=165, 168)
|
0.91 event rate (events/subject months)
|
1.18 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M6 (n=162, 167)
|
0.87 event rate (events/subject months)
|
1.20 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M7 (n=161, 167)
|
1.10 event rate (events/subject months)
|
1.41 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M8 (n=158, 164)
|
0.82 event rate (events/subject months)
|
1.34 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M9 (n=158, 164)
|
0.56 event rate (events/subject months)
|
1.25 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M10 (n=156, 164)
|
0.99 event rate (events/subject months)
|
1.11 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M11 (n=153, 164)
|
0.70 event rate (events/subject months)
|
0.92 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M12 (n=152, 162)
|
1.26 event rate (events/subject months)
|
1.25 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M13 (n=152, 160)
|
1.07 event rate (events/subject months)
|
1.14 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M14 (n=151, 159)
|
0.95 event rate (events/subject months)
|
1.01 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M15 (n=149, 156)
|
0.86 event rate (events/subject months)
|
1.25 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M16 (n=149, 156)
|
0.99 event rate (events/subject months)
|
1.23 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M17 (n=148, 154)
|
1.20 event rate (events/subject months)
|
1.01 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M18 (n=146, 154)
|
1.08 event rate (events/subject months)
|
1.05 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M36 (n=51, 60)
|
0.72 event rate (events/subject months)
|
0.47 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Overall comparative (n=315, 303)
|
0.95 event rate (events/subject months)
|
1.19 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Overall extension (n=172, 169)
|
0.89 event rate (events/subject months)
|
1.10 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M19 (n=143, 152)
|
1.25 event rate (events/subject months)
|
1.21 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M20 (n=142, 152)
|
1.20 event rate (events/subject months)
|
1.08 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M21 (n=141, 151)
|
0.78 event rate (events/subject months)
|
1.15 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M22 (n=141, 149)
|
0.79 event rate (events/subject months)
|
1.08 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M23 (n=139, 149)
|
0.82 event rate (events/subject months)
|
1.06 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M24 (n=138, 147)
|
0.88 event rate (events/subject months)
|
1.11 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M25 (n=137, 146)
|
0.73 event rate (events/subject months)
|
1.22 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M26 (n=137, 145)
|
0.68 event rate (events/subject months)
|
1.25 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M27 (n=137, 141)
|
0.62 event rate (events/subject months)
|
1.04 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M28 (n=135, 137)
|
0.68 event rate (events/subject months)
|
0.87 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M29 (n=135, 137)
|
0.81 event rate (events/subject months)
|
0.91 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M30 (n=133, 137)
|
0.64 event rate (events/subject months)
|
0.87 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M31 (n=124, 133)
|
0.67 event rate (events/subject months)
|
1.32 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M32 (n=117, 125)
|
0.82 event rate (events/subject months)
|
0.81 event rate (events/subject months)
|
|
Hypoglycemic Event Rates
Ext M33 (n=100, 117)
|
0.55 event rate (events/subject months)
|
0.89 event rate (events/subject months)
|
SECONDARY outcome
Timeframe: Month 1 through extension Month 36Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 (\[total events/subject months\]\*100). Subjects months: elapsed number of months subject was in study in each time interval.
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=315 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=303 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Severe Hypoglycemic Event Rates
M11 (n=267, 274)
|
0.38 event rate (events/subject months*100)
|
0.37 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M12 (n=264, 274)
|
0.76 event rate (events/subject months*100)
|
0.37 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M13 (n=263, 269)
|
0.77 event rate (events/subject months*100)
|
0.76 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M1 (n=315, 303)
|
0.98 event rate (events/subject months*100)
|
0.67 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M14 (n=260, 265)
|
0.78 event rate (events/subject months*100)
|
0.38 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M15 (n=256, 265)
|
0.79 event rate (events/subject months*100)
|
0.77 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M16 (n=254, 261)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M17 (n=252, 257)
|
0.00 event rate (events/subject months*100)
|
0.40 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M18 (n=246, 253)
|
0.00 event rate (events/subject months*100)
|
0.40 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M19 (n=245, 252)
|
0.41 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M20 (n=242, 249)
|
0.42 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M21 (n=241, 246)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M22 (n=236, 244)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M23 (n=236, 241)
|
0.00 event rate (events/subject months*100)
|
0.85 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M24 (n=229, 232)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M1 (n=172, 169
|
0.95 event rate (events/subject months*100)
|
0.93 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M2 (n=171, 169)
|
0.00 event rate (events/subject months*100)
|
1.87 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M3 (n=169, 169)
|
1.92 event rate (events/subject months*100)
|
0.94 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M4 (n=167, 169)
|
1.92 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M5 (n=165, 168)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M6 (n=162, 167)
|
0.00 event rate (events/subject months*100)
|
0.94 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M7 (n=161, 167)
|
0.00 event rate (events/subject months*100)
|
1.90 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M8 (n=158, 164)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M9 (n=158, 164)
|
0.00 event rate (events/subject months*100)
|
2.86 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M10 (n=156, 164)
|
0.00 event rate (events/subject months*100)
|
3.81 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M11 (n=153, 164)
|
0.00 event rate (events/subject months*100)
|
3.86 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M12 (n=152, 162)
|
0.98 event rate (events/subject months*100)
|
3.91 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M13 (n=152, 160)
|
0.00 event rate (events/subject months*100)
|
0.98 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M14 (n=151, 159)
|
0.00 event rate (events/subject months*100)
|
1.96 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M15 (n=149, 156)
|
1.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M16 (n=149, 156)
|
1.00 event rate (events/subject months*100)
|
1.96 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M17 (n=148, 154)
|
1.00 event rate (events/subject months*100)
|
0.99 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M18 (n=146, 154)
|
1.01 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M19 (n=143, 152)
|
1.03 event rate (events/subject months*100)
|
0.99 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M20 (n=142, 152)
|
4.16 event rate (events/subject months*100)
|
0.99 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M21 (n=141, 151)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M22 (n=141, 149)
|
0.00 event rate (events/subject months*100)
|
1.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M23 (n=139, 149)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M24 (n=138, 147)
|
1.06 event rate (events/subject months*100)
|
2.02 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M25 (n=137, 146)
|
0.00 event rate (events/subject months*100)
|
1.01 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M26 (n=137, 145)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M27 (n=137, 141)
|
1.07 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M28 (n=135, 137)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M29 (n=135, 137)
|
0.00 event rate (events/subject months*100)
|
1.06 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M30 (n=133, 137)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M31 (n=124, 133)
|
0.00 event rate (events/subject months*100)
|
1.15 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M32 (n=117, 125)
|
0.00 event rate (events/subject months*100)
|
3.58 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M33 (n=100, 117)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M34 (n=84, 90)
|
0.00 event rate (events/subject months*100)
|
1.89 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M35 (n=66, 78)
|
0.00 event rate (events/subject months*100)
|
0.00 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Ext M36 (n=51, 60)
|
0.00 event rate (events/subject months*100)
|
0.82 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Overall comparative (n=315, 303)
|
0.45 event rate (events/subject months*100)
|
0.65 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
Overall extension (n=172, 169)
|
0.50 event rate (events/subject months*100)
|
1.17 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M2 (n=307, 302)
|
0.34 event rate (events/subject months*100)
|
0.34 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M3 (n=297, 298)
|
0.69 event rate (events/subject months*100)
|
0.34 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M4 (n=289, 295)
|
0.35 event rate (events/subject months*100)
|
1.38 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M5 (n=284, 293)
|
0.36 event rate (events/subject months*100)
|
1.74 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M6 (n=283, 290)
|
0.72 event rate (events/subject months*100)
|
2.10 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M7 (n=280, 289)
|
0.00 event rate (events/subject months*100)
|
0.70 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M8 (n=276, 288)
|
0.37 event rate (events/subject months*100)
|
0.70 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M9 (n=275, 287)
|
0.74 event rate (events/subject months*100)
|
0.35 event rate (events/subject months*100)
|
|
Severe Hypoglycemic Event Rates
M10 (n=273, 285)
|
0.00 event rate (events/subject months*100)
|
0.36 event rate (events/subject months*100)
|
SECONDARY outcome
Timeframe: Week 0 and if indicated through extension follow up Month 3Population: FAS. Due to early termination of study a limited set of analyses were undertaken and results of Cough Questionnaire were not summarized as planned.
Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week -1Population: FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of BDI were not summarized as planned.
Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4 through extension follow up Month 3 or end of studyPopulation: FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TDI were not summarized as planned.
Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, M12, M24, Ext M6, Ext M18, Ext M36Population: All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.
Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline.
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=71 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=76 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
M12 = Yes
|
67 participants
|
64 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
M12 = No
|
4 participants
|
12 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
M24 = Yes
|
38 participants
|
51 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
M24 = No
|
8 participants
|
10 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Ext M6 = Yes
|
32 participants
|
37 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Ext M6 = No
|
8 participants
|
8 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Ext M18 = Yes
|
28 participants
|
33 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Ext M18 = No
|
8 participants
|
6 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Ext M36 = Yes
|
22 participants
|
27 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Ext M36 = No
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline, M12, M24, Ext M6, Ext M18, Ext M36Population: All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.
Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. "No" response at observation further categorized as no significant change (NSC), more abnormal (\> Abn), or less abnormal (\< Abn).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=26 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=21 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M24 = Yes
|
5 participants
|
2 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M18 = No (< Abn)
|
1 participants
|
0 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M24 = No (NSC)
|
17 participants
|
8 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M6 = Yes
|
3 participants
|
3 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M24 = No (< Abn)
|
0 participants
|
0 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M6 = No
|
16 participants
|
9 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M6 = No (NSC)
|
15 participants
|
8 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M6 = No (> Abn)
|
1 participants
|
1 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M6 = No (< Abn)
|
0 participants
|
0 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M18 = Yes
|
3 participants
|
2 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M18 = No
|
14 participants
|
7 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M18 = No (NSC)
|
12 participants
|
7 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M18 = No (> Abn)
|
1 participants
|
0 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M12 = Yes
|
6 participants
|
5 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M12 = No
|
20 participants
|
16 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M12 = No (NSC)
|
19 participants
|
11 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M12 = No (> Abn)
|
0 participants
|
2 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M12 = No (< Abn)
|
1 participants
|
3 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M24 = Yes
|
4 participants
|
6 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M24 = No
|
17 participants
|
9 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
M24 = No (> Abn)
|
0 participants
|
1 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M24 = No
|
9 participants
|
8 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M24 = No (NSC)
|
8 participants
|
8 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M24 = No (> Abn)
|
1 participants
|
0 participants
|
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Ext M24 = No (< Abn)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through extension Month 36Population: FAS; (n)=number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.
Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).
Outcome measures
| Measure |
Inhaled Insulin (Exubera®)
n=312 Participants
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=300 Participants
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Insulin Antibodies
Baseline (n=312, 300)
|
1.05 microU/mL
Interval 1.05 to 328.0
|
1.05 microU/mL
Interval 1.05 to 1077.0
|
|
Insulin Antibodies
W3 (n=270, 264)
|
1.05 microU/mL
Interval 1.05 to 948.0
|
1.05 microU/mL
Interval 1.05 to 552.0
|
|
Insulin Antibodies
W6 (n=289, 282)
|
4.40 microU/mL
Interval 1.05 to 7296.0
|
1.05 microU/mL
Interval 1.05 to 2123.0
|
|
Insulin Antibodies
M3 (n=293, 289)
|
12.00 microU/mL
Interval 1.05 to 2748.0
|
1.05 microU/mL
Interval 1.05 to 4016.0
|
|
Insulin Antibodies
W18 (n=275, 280)
|
18.00 microU/mL
Interval 1.05 to 1051.0
|
1.05 microU/mL
Interval 1.05 to 3648.0
|
|
Insulin Antibodies
M6 (n=276, 279)
|
20.00 microU/mL
Interval 1.05 to 1424.0
|
1.05 microU/mL
Interval 1.05 to 3380.0
|
|
Insulin Antibodies
M9 (n=267, 277)
|
22.00 microU/mL
Interval 1.05 to 1776.0
|
1.05 microU/mL
Interval 1.05 to 3412.0
|
|
Insulin Antibodies
M12 (n=263, 263)
|
19.00 microU/mL
Interval 1.05 to 1464.0
|
1.05 microU/mL
Interval 1.05 to 1200.0
|
|
Insulin Antibodies
M15 (n=252, 253)
|
20.00 microU/mL
Interval 1.05 to 1760.0
|
1.05 microU/mL
Interval 1.05 to 1780.0
|
|
Insulin Antibodies
M18 (n=241, 239)
|
20.00 microU/mL
Interval 1.05 to 1680.0
|
1.05 microU/mL
Interval 1.05 to 1820.0
|
|
Insulin Antibodies
M21 (n=234, 233)
|
19.00 microU/mL
Interval 1.05 to 1331.0
|
1.05 microU/mL
Interval 1.05 to 2230.0
|
|
Insulin Antibodies
M24 (n=226, 233)
|
20.00 microU/mL
Interval 1.05 to 1330.0
|
1.05 microU/mL
Interval 1.05 to 1965.0
|
|
Insulin Antibodies
FU M1 (n=247, 226)
|
14.00 microU/mL
Interval 1.05 to 974.0
|
1.05 microU/mL
Interval 1.05 to 2135.0
|
|
Insulin Antibodies
FU M3 (n=249, 229)
|
8.50 microU/mL
Interval 1.05 to 686.0
|
1.05 microU/mL
Interval 1.05 to 1070.0
|
|
Insulin Antibodies
FU M6 (n=250, 227)
|
6.55 microU/mL
Interval 1.05 to 641.0
|
1.05 microU/mL
Interval 1.05 to 1480.0
|
|
Insulin Antibodies
Ext M1 (n=165, 160)
|
13.00 microU/mL
Interval 1.05 to 894.0
|
1.05 microU/mL
Interval 1.05 to 1270.0
|
|
Insulin Antibodies
Ext M3 (n=159, 158)
|
15.00 microU/mL
Interval 1.05 to 755.0
|
1.05 microU/mL
Interval 1.05 to 765.0
|
|
Insulin Antibodies
Ext M6 (n=157, 156)
|
12.00 microU/mL
Interval 1.05 to 1200.0
|
1.05 microU/mL
Interval 1.05 to 612.0
|
|
Insulin Antibodies
Ext M9 (n=150, 157)
|
11.50 microU/mL
Interval 1.05 to 1855.0
|
1.05 microU/mL
Interval 1.05 to 905.0
|
|
Insulin Antibodies
Ext M12 (n=148, 154)
|
13.00 microU/mL
Interval 1.05 to 1535.0
|
1.05 microU/mL
Interval 1.05 to 683.0
|
|
Insulin Antibodies
Ext M15 (n=144, 147)
|
10.50 microU/mL
Interval 1.05 to 1860.0
|
1.05 microU/mL
Interval 1.05 to 770.0
|
|
Insulin Antibodies
Ext M18 (n=140, 144)
|
13.00 microU/mL
Interval 1.05 to 1080.0
|
1.05 microU/mL
Interval 1.05 to 455.0
|
|
Insulin Antibodies
Ext M21 (n=136, 145)
|
12.00 microU/mL
Interval 1.05 to 801.0
|
1.05 microU/mL
Interval 1.05 to 620.0
|
|
Insulin Antibodies
Ext M24 (n=130, 135)
|
10.50 microU/mL
Interval 1.05 to 831.0
|
1.05 microU/mL
Interval 1.05 to 696.0
|
|
Insulin Antibodies
Ext M27 (n=129, 131)
|
12.00 microU/mL
Interval 1.05 to 885.0
|
2.50 microU/mL
Interval 1.05 to 208.0
|
|
Insulin Antibodies
Ext M30 (n=125, 127)
|
8.40 microU/mL
Interval 1.05 to 510.0
|
1.05 microU/mL
Interval 1.05 to 429.0
|
|
Insulin Antibodies
Ext M33 (n=103, 114)
|
9.20 microU/mL
Interval 1.05 to 700.0
|
1.05 microU/mL
Interval 1.05 to 637.0
|
|
Insulin Antibodies
Ext M36 (n=56, 63)
|
5.75 microU/mL
Interval 1.05 to 168.0
|
1.05 microU/mL
Interval 1.05 to 321.0
|
Adverse Events
Inhaled Insulin (Exubera®)
Serious events: 76 serious events
Other events: 308 other events
Deaths: 0 deaths
Subcutaneous Insulin
Serious events: 76 serious events
Other events: 301 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Insulin (Exubera®)
n=316 participants at risk
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=311 participants at risk
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Infections and infestations
Peritonsillar abscess
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Pneumonia
|
0.63%
2/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.96%
3/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Acute myocardial infarctionAcute myocardial infarction
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Angina unstable
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.96%
3/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Arrhythmia
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Bradycardia
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
5/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.96%
3/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
4/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
1.6%
5/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Ear and labyrinth disorders
Vertigo
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
1.3%
4/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Lip swelling
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Melaena
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Chest discomfort
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Chest pain
|
0.63%
2/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
1.6%
5/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Non-cardiac chest pain
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Pyrexia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Appendicitis
|
0.95%
3/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Bronchitis
|
0.63%
2/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Cellulitis
|
2.2%
7/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
1.6%
5/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Diverticulitis
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Lobar pneumonia
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Osteomyelitis
|
0.95%
3/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Post procedural infection
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Sepsis syndrome
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Skin infection
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Urinary tract infection
|
0.63%
2/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Wound infection
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Device migration
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Failure of implant
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Investigations
Heart rate irregular
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
4/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
3.9%
12/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.63%
2/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.96%
3/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
4/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Cataplexy
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.63%
2/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Dizziness
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Facial palsy
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Global amnesia
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Migraine
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Radiculopathy
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Syncope
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Bipolar II disorder
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Depression
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Renal and urinary disorders
Renal cyst
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Surgical and medical procedures
Hysterectomy
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Surgical and medical procedures
Vascular operation
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Arterial occlusive disease
|
0.63%
2/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Hypertension
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Hypotension
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.32%
1/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.64%
2/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.32%
1/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
Other adverse events
| Measure |
Inhaled Insulin (Exubera®)
n=316 participants at risk
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
|
Subcutaneous Insulin
n=311 participants at risk
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
13/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.1%
16/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.5%
49/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
8.7%
27/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.0%
19/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
4.8%
15/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Nausea
|
7.6%
24/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
9.3%
29/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
15/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.5%
17/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Asthenia
|
7.3%
23/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
6.8%
21/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Chest pain
|
6.3%
20/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
6.4%
20/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Fatigue
|
6.0%
19/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
9.6%
30/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Oedema peripheral
|
12.0%
38/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
13.5%
42/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Immune system disorders
Seasonal allergy
|
3.8%
12/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
6.8%
21/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Bronchitis
|
14.2%
45/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
7.1%
22/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Cellulitis
|
5.7%
18/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
2.6%
8/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Gastroenteritis
|
4.4%
14/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.5%
17/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Gastroenteritis viral
|
7.3%
23/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.5%
17/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Influenza
|
19.9%
63/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
24.4%
76/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.0%
22/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
4.5%
14/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Nasopharyngitis
|
26.3%
83/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
30.2%
94/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Sinusitis
|
13.0%
41/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
14.8%
46/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Upper respiratory tract infection
|
32.9%
104/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
32.5%
101/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Urinary tract infection
|
9.2%
29/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
9.6%
30/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.7%
18/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.8%
18/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
77.5%
245/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
79.4%
247/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
51/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
13.8%
43/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
43/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
16.7%
52/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.4%
14/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.1%
16/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.6%
21/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
6.8%
21/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
16/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.1%
16/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.7%
15/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.1%
16/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
41/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
13.8%
43/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Dizziness
|
11.7%
37/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
14.5%
45/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Headache
|
13.6%
43/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
9.0%
28/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Hypoaesthesia
|
6.0%
19/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
6.4%
20/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Tremor
|
11.7%
37/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
16.1%
50/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Depression
|
6.6%
21/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
12.9%
40/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.9%
142/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
22.5%
70/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
24/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.5%
17/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.5%
11/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
6.8%
21/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.2%
29/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
9.3%
29/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
16/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
1.6%
5/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.3%
20/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
8.7%
27/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.6%
21/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
9.6%
30/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
17/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.1%
16/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Hypertension
|
16.5%
52/316
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
19.9%
62/311
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER