Trial Outcomes & Findings for A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression (NCT NCT03103152)
NCT ID: NCT03103152
Last Updated: 2023-03-29
Results Overview
The proportion of eligible patients that join the trial over the 12-month trial recruitment period.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
104 participants
Primary outcome timeframe
12 months
Results posted on
2023-03-29
Participant Flow
12 months recruitment (December 2016 to Dec 2017). All recruitment took place in the hospital setting within active surveillance clinics.
Helicobacter pylori (H. pylori) has been shown to be a causative factor in GI bleeding, so all participants were tested for this at randomisation as a precaution. Patients who tested positive were prescribed a course of proton pump inhibitors(PPIs) \& antibiotics if they wished to continue on the study. GPs were informed. Serum calcium levels were also checked at baseline. Anyone with symptoms of hypercalcaemia was excluded.
Participant milestones
| Measure |
High Dose Aspirin & Vitamin D
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
19
|
18
|
16
|
18
|
|
Overall Study
COMPLETED
|
7
|
10
|
8
|
9
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
11
|
9
|
6
|
9
|
Reasons for withdrawal
| Measure |
High Dose Aspirin & Vitamin D
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
5
|
2
|
6
|
3
|
3
|
1
|
|
Overall Study
Protocol Violation
|
2
|
2
|
1
|
2
|
1
|
1
|
|
Overall Study
Inter-current illness
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
1
|
1
|
|
Overall Study
Patient wishes to come off active surveillance
|
2
|
0
|
1
|
1
|
1
|
3
|
|
Overall Study
Unacceptable side effects
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Testicular pain
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Dose Aspirin & Vitamin D
n=17 Participants
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
n=16 Participants
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
n=19 Participants
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
n=18 Participants
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
n=16 Participants
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
n=18 Participants
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56 Years
n=17 Participants
|
61 Years
n=16 Participants
|
62 Years
n=19 Participants
|
59.5 Years
n=18 Participants
|
64 Years
n=16 Participants
|
65.5 Years
n=18 Participants
|
61 Years
n=104 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=17 Participants
|
16 Participants
n=16 Participants
|
19 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
16 Participants
n=16 Participants
|
18 Participants
n=18 Participants
|
104 Participants
n=104 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Number accrued by arm over the 12 month recruitment period.
The proportion of eligible patients that join the trial over the 12-month trial recruitment period.
Outcome measures
| Measure |
High Dose Aspirin & Vitamin D
n=17 Participants
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
n=16 Participants
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
n=19 Participants
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
n=18 Participants
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
n=16 Participants
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
n=18 Participants
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month.
|
17 Participants
|
16 Participants
|
19 Participants
|
18 Participants
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All participants with a baseline \& 12 mth MRI scan.
Radiological progression was defined as 'development of a Prostate Imaging-Reporting and Data System (PI-RADS) 4/5 lesion (17) on mpMRI, where no lesion was identified before, 33% volume increase in the size of the lesion, or radiological upstaging to T3 or above based on local site reports.' Absence of these features represented radiologically stable disease. Lesion on multi-parametric imaging where no MRI lesion at screening. An MRI scan shows a screening + or - in volume by \> 33%, or an upgrading of MRI stage of disease to ≥3.
Outcome measures
| Measure |
High Dose Aspirin & Vitamin D
n=9 Participants
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
n=8 Participants
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
n=8 Participants
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
n=5 Participants
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
n=9 Participants
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
n=8 Participants
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
Response to Treatment as Determined by Serial Multi-parametric Magnetic Resonance Imaging (MRI) of the Prostate. New Lesion Present or Existing Lesion + or - in Size.
Disease Regression
|
1 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Response to Treatment as Determined by Serial Multi-parametric Magnetic Resonance Imaging (MRI) of the Prostate. New Lesion Present or Existing Lesion + or - in Size.
Stable Disease
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Response to Treatment as Determined by Serial Multi-parametric Magnetic Resonance Imaging (MRI) of the Prostate. New Lesion Present or Existing Lesion + or - in Size.
Disease Progression
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Number of subjects analysed
50% increase in serum Prostate Specific Antigen at 12 months from baseline.
Outcome measures
| Measure |
High Dose Aspirin & Vitamin D
n=12 Participants
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
n=13 Participants
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
n=11 Participants
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
n=10 Participants
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
n=12 Participants
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
n=15 Participants
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Biochemical (PSA) Disease Progression
Disease Regression
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Biochemical (PSA) Disease Progression
Stable Disease
|
9 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With Biochemical (PSA) Disease Progression
Disease Progression
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 yearsHistological disease progression will be defined as an increase in Gleason scores from: Gleason 3+3 to Gleason score 7 or higher Gleason 3+4 (score 7) to 4+3 (score 7) or Gleason 4+3 to a higher score Or a 50% increase in maximum cancer core length (MCCL)
Outcome measures
| Measure |
High Dose Aspirin & Vitamin D
n=17 Participants
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
n=16 Participants
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
n=19 Participants
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
n=18 Participants
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
n=16 Participants
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
n=18 Participants
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Histological Disease Progression
|
2 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 18 months + 30 daysPopulation: Total intention to treat population.
Aspirin toxicity: Haemorrhagic stroke, anaphylaxis following administration, gastrointestinal bleeding requiring intervention (both medical and surgical) Vitamin D3 toxicity: Hypercalcaemia, Anaphylaxis
Outcome measures
| Measure |
High Dose Aspirin & Vitamin D
n=17 Participants
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
n=16 Participants
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
n=19 Participants
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
n=18 Participants
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
n=16 Participants
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
n=18 Participants
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
None of the above toxicities
|
17 Participants
|
16 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
17 Participants
|
|
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
Haemorrhagic Stroke
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
Rectal Bleeding
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
Anaphylaxis either Vit D or Aspirin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
Hypercalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
High Dose Aspirin & Vitamin D
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
High Dose Aspirin, Vitamin D Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Low Dose Aspirin , Vitamin D
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Low Dose Aspirin, Vitamin D Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Aspirin Placebo, Vitamin D
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Aspirin Placebo, Vitamin D Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose Aspirin & Vitamin D
n=17 participants at risk
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
n=16 participants at risk
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
n=19 participants at risk
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
n=18 participants at risk
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
n=16 participants at risk
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
n=18 participants at risk
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Mass in brain
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Renal and urinary disorders
Urinary Retention Post-operative
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Infections and infestations
Febrile Infection
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
Other adverse events
| Measure |
High Dose Aspirin & Vitamin D
n=17 participants at risk
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin \& Vitamin D: Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
High Dose Aspirin, Vitamin D Placebo
n=16 participants at risk
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo: Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin , Vitamin D
n=19 participants at risk
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Low Dose Aspirin, Vitamin D Placebo
n=18 participants at risk
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo: Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
|
Aspirin Placebo, Vitamin D
n=16 participants at risk
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D: Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D: Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
Aspirin Placebo, Vitamin D Placebo
n=18 participants at risk
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo: Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
|
|---|---|---|---|---|---|---|
|
General disorders
Abdominal aortic aneurysm
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Abdominal crampy pains
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Acid Reflux
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Acute Back Pain
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Arm Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Renal and urinary disorders
Blood in urine
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Blood Pressure Increased
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Blood in stool
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Chest Infection
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Coccyx Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Cold
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
12.5%
2/16 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
16.7%
3/18 • Number of events 3 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Cardiac disorders
Fast Heart Beat
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Foot Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Fractured Ribs
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Haemospermia
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Hay Fever
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Head Cold
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Indigestion
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Mouth Ulceration
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Nose Bleed
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
18.8%
3/16 • Number of events 3 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
11.1%
2/18 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Stomach Pain
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Prolapsing Haemorrhoid
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Rectal Bleeding
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Sore Throat
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
18.8%
3/16 • Number of events 3 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Stomach Acid
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Swelling Right Testicle
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Swollen Toes
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Toothache
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Reproductive system and breast disorders
Haematuria
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
18.8%
3/16 • Number of events 3 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
12.5%
2/16 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
10.5%
2/19 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
11.1%
2/18 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Lower urinary tract symptoms
|
11.8%
2/17 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Nocturia
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Urinary Retention
|
11.8%
2/17 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
1/17 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.3%
1/19 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Back Ache
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Bacterial Infection
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
11.1%
2/18 • Number of events 2 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Bleeding Post-op
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Chest Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Dark Circles Under Eyes
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Fever
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Flu-like symptoms
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Flu Prophylaxis
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Haematuria
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Left Hip Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Left Knee Meniscal Tear
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Leg Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Lichen Simplex
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Pain in hips, knees, shoulders
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Pins & Needles
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Polymyalgia Rheumatica
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Post-op Pain
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Rash, headache, insomnia
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Removal of basal cell
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Stomach Ache
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Upset Stomach
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
General disorders
Urinary Urgency
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Eye disorders
Teary Eyes
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Ear and labyrinth disorders
Ear Infection
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Gastrointestinal disorders
Gastrooesophageal relux disease
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
|
Infections and infestations
Fever
|
0.00%
0/17 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/19 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/18 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
0.00%
0/16 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored/assessed from the date of first randomisation (in December 2016) until the end of the trial (June 2018) +30 day pharmacovigilance period Overall: AEs reported from the date of each patient's randomisation until their last visit within 18 months after randomisation + 30 days pharmacovigilance. Per patient: participants were followed from the point of recruitment until 18 months after recruitment for each participant +30 days for pharmacovigilance.
Since there is no risk arising from the transfer of any PROVENT IMP products via seminal fluid, it has been deemed unnecessary to collect \& record pregnancies where the father is a PROVENT study participant. Mild: Some discomfort noted but without disruption of daily life Moderate: Discomfort enough to affect/reduce normal activity Severe: Complete inability to perform daily activities and lead a normal life Unknown. Intensity not be confused with regulatory definition "serious".
|
Additional Information
Professor Jack Cuzick, Director of The Wolfson Institute
Queen Mary University, London.
Phone: +44 (0)207 882 3504
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The NHS Organisation shall not publish/disseminate the conclusions of the Study, including all or any part of the Results of the Study without the prior written consent of the Sponsor. Any publication/dissemination of the conclusions of the Study by the NHS Organisation shall not occur until the Sponsor has published the conclusions of the Study in accordance with clause 7.2 and shall refer to publication by the Sponsor in such form as the Sponsor may reasonably direct.
- Publication restrictions are in place
Restriction type: OTHER