Trial Outcomes & Findings for Study of FORTEO Use in Subjects in the Community Setting (NCT NCT01078805)
NCT ID: NCT01078805
Last Updated: 2012-06-26
Results Overview
Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk \* 100.
Recruitment status
COMPLETED
Target enrollment
4167 participants
Primary outcome timeframe
up to 24 months
Results posted on
2012-06-26
Participant Flow
Participant milestones
| Measure |
FORTEO (Teriparatide)-Treated
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Overall Study
STARTED
|
4167
|
|
Overall Study
Took at Least 1 Dose of Study Drug
|
4085
|
|
Overall Study
Modified Intent-To-Treat
|
3720
|
|
Overall Study
COMPLETED
|
2117
|
|
Overall Study
NOT COMPLETED
|
2050
|
Reasons for withdrawal
| Measure |
FORTEO (Teriparatide)-Treated
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Overall Study
Clinically significant abnormal lab
|
5
|
|
Overall Study
Death
|
134
|
|
Overall Study
Lost to Follow-up
|
676
|
|
Overall Study
Physician Decision
|
169
|
|
Overall Study
Serious adverse event
|
26
|
|
Overall Study
Sponsor decision
|
46
|
|
Overall Study
Withdrawal by Subject
|
739
|
|
Overall Study
Other
|
173
|
|
Overall Study
Didn't take study drug
|
82
|
Baseline Characteristics
Study of FORTEO Use in Subjects in the Community Setting
Baseline characteristics by cohort
| Measure |
FORTEO (Teriparatide)-Treated
n=3720 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Age Continuous
|
67.96 years
STANDARD_DEVIATION 11.72 • n=93 Participants
|
|
Sex/Gender, Customized
Female
|
3350 participants
n=93 Participants
|
|
Sex/Gender, Customized
Male
|
369 participants
n=93 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African
|
57 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3282 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
29 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
321 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
18 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
3720 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
New osteoporotic fracture
|
848 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
Multiple fracture risk factors - per investigator
|
3395 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
Inadequate response to previous therapy
|
2261 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
Participant met Forteo threshold -per investigator
|
2215 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
Intolerance to previous osteoporosis therapy
|
891 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
Adequate insurance coverage
|
925 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
Absence of prior authorization criteria
|
193 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
Participant request
|
247 participants
n=93 Participants
|
|
Physician Criteria for Initiating FORTEO Therapy
Height loss
|
697 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 24 monthsPopulation: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.
Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk \* 100.
Outcome measures
| Measure |
FORTEO (Teriparatide)-Treated
n=3720 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Percentage of Participants With Non-Vertebral Fragility Fractures
0 to 6 months (n=3720)
|
1.42 Percentage of participants
|
|
Percentage of Participants With Non-Vertebral Fragility Fractures
6 to 12 months (n=2970)
|
0.91 Percentage of participants
|
|
Percentage of Participants With Non-Vertebral Fragility Fractures
12 to 18 months (n=2570)
|
0.70 Percentage of participants
|
|
Percentage of Participants With Non-Vertebral Fragility Fractures
18 to 24 months (n=2225)
|
0.81 Percentage of participants
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.
Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk \* 100.
Outcome measures
| Measure |
FORTEO (Teriparatide)-Treated
n=3720 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Percentage of Participants With Clinical Vertebral Fractures
0 to 6 months (n=3720)
|
0.67 Percentage of participants
|
|
Percentage of Participants With Clinical Vertebral Fractures
6 to 12 months (n=2996)
|
0.40 Percentage of participants
|
|
Percentage of Participants With Clinical Vertebral Fractures
12 to 18 months (n=2606)
|
0.35 Percentage of participants
|
|
Percentage of Participants With Clinical Vertebral Fractures
18 to 24 months (n=2266)
|
0.35 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.
Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit\*100%.
Outcome measures
| Measure |
FORTEO (Teriparatide)-Treated
n=289 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint
|
-36.2 percentage change of pain score
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.
Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit\*100%.
Outcome measures
| Measure |
FORTEO (Teriparatide)-Treated
n=375 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint
|
-24.9 percentage change of pain score
Standard Error 2.2
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.
Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.
Outcome measures
| Measure |
FORTEO (Teriparatide)-Treated
n=3720 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Treatment Adherence
0 to 6 months (n=701)
|
72.5 days
Standard Deviation 54.5
|
|
Treatment Adherence
6 to 12 months (n=382)
|
272.5 days
Standard Deviation 57.7
|
|
Treatment Adherence
12 to 18 months (n=338)
|
450.7 days
Standard Deviation 59.0
|
|
Treatment Adherence
18 to 24 months (n=2299)
|
743.7 days
Standard Deviation 115.7
|
SECONDARY outcome
Timeframe: Baseline, up to month 24Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.
A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).
Outcome measures
| Measure |
FORTEO (Teriparatide)-Treated
n=835 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
Total Hip
|
3.766 percentage (%) change of BMD
Standard Error 1.721
|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
Trochanter
|
2.604 percentage (%) change of BMD
Standard Error 1.186
|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
Wards Triangle
|
3.394 percentage (%) change of BMD
Standard Error 0.761
|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
Femoral Neck
|
2.569 percentage (%) change of BMD
Standard Error 0.944
|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
Forearm
|
0.626 percentage (%) change of BMD
Standard Error 1.421
|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
Inter-Trochanter
|
1.532 percentage (%) change of BMD
Standard Error 0.413
|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
Lumbar spine vertebrae numbered 1 through 4(L1-L4)
|
6.419 percentage (%) change of BMD
Standard Error 0.334
|
SECONDARY outcome
Timeframe: Baseline, up to month 24Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.
BMC is an estimate of the amount of mineral (such as calcium) in the bone.
Outcome measures
| Measure |
FORTEO (Teriparatide)-Treated
n=590 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
Femoral Neck
|
4.187 percentage (%) change of grams (g)
Standard Error 1.707
|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
Forearm
|
7.243 percentage (%) change of grams (g)
Standard Error 7.995
|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
Inter-Trochanter
|
5.716 percentage (%) change of grams (g)
Standard Error 2.684
|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
L1-L4
|
20.774 percentage (%) change of grams (g)
Standard Error 11.226
|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
Total Hip
|
8.303 percentage (%) change of grams (g)
Standard Error 6.866
|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
Trochanter
|
4.968 percentage (%) change of grams (g)
Standard Error 2.899
|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
Wards Triangle
|
50.996 percentage (%) change of grams (g)
Standard Error 30.540
|
SECONDARY outcome
Timeframe: Baseline, up to month 24Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.
Bone area is a defined region of interest of bone.
Outcome measures
| Measure |
FORTEO (Teriparatide)-Treated
n=591 Participants
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Femoral Neck
|
2.231 percent change of centimeter square
Standard Error 1.336
|
|
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Forearm
|
4.680 percent change of centimeter square
Standard Error 4.705
|
|
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Inter-Trochanter
|
1.828 percent change of centimeter square
Standard Error 0.661
|
|
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
L1-L4
|
3.907 percent change of centimeter square
Standard Error 1.242
|
|
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Total Hip
|
2.648 percent change of centimeter square
Standard Error 1.453
|
|
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Trochanter
|
3.395 percent change of centimeter square
Standard Error 2.375
|
|
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Wards Triangle
|
1.826 percent change of centimeter square
Standard Error 1.171
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants are those who took at least one dose of study drug and had reasons documented to initiate Forteo therapy. This is a baseline characteristic; therefore data are presented in the section of Baseline Characteristics.
Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here.
Outcome measures
Outcome data not reported
Adverse Events
FORTEO (Teriparatide)-Treated
Serious events: 432 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FORTEO (Teriparatide)-Treated
n=4085 participants at risk
FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Angina pectoris
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Angina unstable
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Arrhythmia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
11/4085 • Number of events 11
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Atrial flutter
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Atrial tachycardia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Bradycardia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Cardiac arrest
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Cardiac disorder
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.24%
10/4085 • Number of events 10
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Cardiomyopathy
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Coronary artery perforation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
18/4085 • Number of events 18
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Palpitations
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Pericardial effusion
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Right ventricular failure
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Sinus bradycardia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Sinus tachycardia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Ear and labyrinth disorders
Vertigo
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Endocrine disorders
Goitre
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Eye disorders
Amaurosis fugax
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
5/4085 • Number of events 5
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Colitis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Constipation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Gastritis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.15%
6/4085 • Number of events 6
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Ileus
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
5/4085 • Number of events 5
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Intestinal strangulation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Nausea
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Regurgitation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.34%
14/4085 • Number of events 14
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Volvulus
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Gastrointestinal disorders
Vomiting
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Asthenia
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Chest pain
|
0.24%
10/4085 • Number of events 10
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Chills
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Death
|
0.37%
15/4085 • Number of events 15
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Device occlusion
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Hernia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Impaired healing
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Medical device complication
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Multi-organ failure
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Non-cardiac chest pain
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Pain
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Pyrexia
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
General disorders
Sudden death
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Hepatobiliary disorders
Biliary cirrhosis primary
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.12%
5/4085 • Number of events 5
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Hepatobiliary disorders
Liver disorder
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Anogenital warts
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Appendicitis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Appendicitis perforated
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Arthritis bacterial
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Bronchitis
|
0.15%
6/4085 • Number of events 6
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Bronchitis bacterial
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Bronchopneumonia
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Catheter site infection
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Cellulitis
|
0.17%
7/4085 • Number of events 7
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Clostridial infection
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Device related infection
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Diverticulitis
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Endocarditis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Gastric infection
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Influenza
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Kidney infection
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Labyrinthitis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Lobar pneumonia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Lung infection
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Osteomyelitis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Peritonitis bacterial
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Pneumonia
|
0.91%
37/4085 • Number of events 37
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Post procedural infection
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Postoperative wound infection
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Pyelonephritis acute
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Sepsis
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Septic shock
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Small intestine gangrene
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Streptococcal infection
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
13/4085 • Number of events 13
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Urosepsis
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Infections and infestations
Viral infection
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
38/4085 • Number of events 38
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.22%
9/4085 • Number of events 9
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.54%
22/4085 • Number of events 22
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.12%
5/4085 • Number of events 5
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.12%
5/4085 • Number of events 5
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Investigations
Blood pressure decreased
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Investigations
Blood pressure increased
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Investigations
Bone scan abnormal
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Investigations
Heart rate increased
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Investigations
International normalised ratio increased
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Investigations
Light chain analysis increased
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
10/4085 • Number of events 10
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
8/4085 • Number of events 8
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.27%
11/4085 • Number of events 11
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blast cell crisis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
7/4085 • Number of events 7
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage IV
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage III
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Amnesia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Ataxia
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Brain oedema
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
12/4085 • Number of events 12
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Convulsion
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Dementia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Dizziness
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Dysarthria
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Encephalitis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Headache
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Lacunar infarction
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Paraesthesia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Presyncope
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Radicular pain
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Syncope
|
0.17%
7/4085 • Number of events 7
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.12%
5/4085 • Number of events 5
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Agitation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Bipolar disorder
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Confusional state
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Delirium
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Depression
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Hallucination
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Major depression
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Psychiatric disorders
Suicide attempt
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Calculus bladder
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Haematuria
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Pyuria
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Renal amyloidosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Renal failure
|
0.15%
6/4085 • Number of events 6
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Renal failure acute
|
0.12%
5/4085 • Number of events 5
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Reproductive system and breast disorders
Breast mass
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Reproductive system and breast disorders
Cystocele
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
8/4085 • Number of events 8
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
16/4085 • Number of events 16
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.07%
3/4085 • Number of events 3
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
10/4085 • Number of events 10
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary eosinophilia
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
6/4085 • Number of events 6
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Surgical and medical procedures
Colectomy
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Surgical and medical procedures
Medical device removal
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Aneurysm
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Aortic stenosis
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Deep vein thrombosis
|
0.15%
6/4085 • Number of events 6
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Haematoma
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Hypertension
|
0.12%
5/4085 • Number of events 5
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Hypotension
|
0.05%
2/4085 • Number of events 2
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Intermittent claudication
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Orthostatic hypotension
|
0.10%
4/4085 • Number of events 4
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Superior mesenteric artery syndrome
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
|
Vascular disorders
Venous insufficiency
|
0.02%
1/4085 • Number of events 1
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
|
Other adverse events
Adverse event data not reported
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60