Trial Outcomes & Findings for BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management (NCT NCT00395135)
NCT ID: NCT00395135
Last Updated: 2019-10-02
Results Overview
The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3182 participants
Primary outcome timeframe
52 weeks
Results posted on
2019-10-02
Participant Flow
Participant milestones
| Measure |
Year 1 - Lorcaserin 10 mg BID
lorcaserin 10 mg BID tablets
|
Year 1 - Matching Placebo BID
matching placebo tablets
|
Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)
Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
|
Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2)
Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
|
Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
Patients randomized to placebo in Year 1, completed year 1 and randomized to receive placebo in Year 2.
|
|---|---|---|---|---|---|
|
Year 1
STARTED
|
1595
|
1587
|
0
|
0
|
0
|
|
Year 1
COMPLETED
|
883
|
716
|
0
|
0
|
0
|
|
Year 1
NOT COMPLETED
|
712
|
871
|
0
|
0
|
0
|
|
Year 2
STARTED
|
0
|
0
|
573
|
283
|
697
|
|
Year 2
COMPLETED
|
0
|
0
|
426
|
195
|
507
|
|
Year 2
NOT COMPLETED
|
0
|
0
|
147
|
88
|
190
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
Baseline characteristics by cohort
| Measure |
Year 1 - Lorcaserin 10 mg BID
n=1593 Participants
lorcaserin 10 mg BID tablets
|
Year 1 - Matching Placebo BID
n=1584 Participants
matching placebo tablets
|
Total
n=3177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 11.32 • n=99 Participants
|
44.4 years
STANDARD_DEVIATION 11.11 • n=107 Participants
|
44.1 years
STANDARD_DEVIATION 11.22 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1321 Participants
n=99 Participants
|
1331 Participants
n=107 Participants
|
2652 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
272 Participants
n=99 Participants
|
253 Participants
n=107 Participants
|
525 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: MITT with LOCF
The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.
Outcome measures
| Measure |
Lorcaserin 10 mg BID
n=1538 Participants
lorcaserin 10 mg BID tablets
|
Matching Placebo BID
n=1499 Participants
matching placebo tablets
|
Placebo (Yr 1) / Placebo (Yr 2)
Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
|
|---|---|---|---|
|
Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52
|
47.5 percentage of participants
|
20.3 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 104 weeksPopulation: MITT with LOCF
The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.
Outcome measures
| Measure |
Lorcaserin 10 mg BID
n=380 Participants
lorcaserin 10 mg BID tablets
|
Matching Placebo BID
n=175 Participants
matching placebo tablets
|
Placebo (Yr 1) / Placebo (Yr 2)
Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
|
|---|---|---|---|
|
Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104
|
67.9 percentage of participants
|
50.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: MITT with LOCF
Year 1: The % change in body weight (kg) from baseline to week 52.
Outcome measures
| Measure |
Lorcaserin 10 mg BID
n=1538 Participants
lorcaserin 10 mg BID tablets
|
Matching Placebo BID
n=1499 Participants
matching placebo tablets
|
Placebo (Yr 1) / Placebo (Yr 2)
Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
|
|---|---|---|---|
|
Year 1: Percent Change in Body Weight From Baseline to Week 52
|
-5.87 % change from baseline: body wt (kg)
Standard Error 0.18
|
-2.20 % change from baseline: body wt (kg)
Standard Error 0.18
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: MITT with LOCF
Year 2: The % change in body weight (kg) from week 52 to week 104.
Outcome measures
| Measure |
Lorcaserin 10 mg BID
n=553 Participants
lorcaserin 10 mg BID tablets
|
Matching Placebo BID
n=267 Participants
matching placebo tablets
|
Placebo (Yr 1) / Placebo (Yr 2)
n=665 Participants
Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
|
|---|---|---|---|
|
Year 2: Percent Change in Body Weight From Week 52 to Week 104
|
2.79 % change from baseline: body wt (kg)
Standard Error 0.23
|
5.38 % change from baseline: body wt (kg)
Standard Error 0.31
|
1.15 % change from baseline: body wt (kg)
Standard Error 0.22
|
Adverse Events
Year 1 - Lorcaserin 10 mg BID
Serious events: 38 serious events
Other events: 1324 other events
Deaths: 0 deaths
Year 1 - Matching Placebo BID
Serious events: 37 serious events
Other events: 1203 other events
Deaths: 0 deaths
Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)
Serious events: 15 serious events
Other events: 450 other events
Deaths: 0 deaths
Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)
Serious events: 6 serious events
Other events: 210 other events
Deaths: 0 deaths
Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
Serious events: 24 serious events
Other events: 515 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Year 1 - Lorcaserin 10 mg BID
n=1593 participants at risk
lorcaserin 10 mg BID tablets
|
Year 1 - Matching Placebo BID
n=1584 participants at risk
matching placebo tablets
|
Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)
n=573 participants at risk
lorcaserin 10 mg BID tablets
|
Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)
n=283 participants at risk
lorcaserin 10 mg BID tablets, matching placebo tablets
|
Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
n=697 participants at risk
matching placebo tablets
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Abscess
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
1/283 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Cardiac disorders
Angina unstable
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.13%
2/1584 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.13%
2/1584 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Investigations
Blood pressure increased
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.19%
3/1584 • Number of events 3 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
General disorders
Chest pain
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
2/1593 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.13%
2/1584 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
1/283 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
1/283 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Cystocele
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Diverticulitis
|
0.13%
2/1593 • Number of events 3 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Dysphasia
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
1/283 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
0.13%
2/1593 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Mastoiditis
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
1/283 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Congenital, familial and genetic disorders
Multiple congenital abnormalities
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Nervous system disorder
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.13%
2/1593 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.19%
3/1584 • Number of events 3 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
2/573 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
1/283 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Pneumonia
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
1/283 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
2/1593 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
1/283 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Radiculitis
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Radiculopathy
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Rectocele
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.35%
2/573 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Sinusitis
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Psychiatric disorders
Suicide attempt
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma benign
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/1584 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.14%
1/697 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.06%
1/1593 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.13%
2/1584 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.43%
3/697 • Number of events 3 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Uterine malposition
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/573 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/1593 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.06%
1/1584 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/283 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.00%
0/697 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
Other adverse events
| Measure |
Year 1 - Lorcaserin 10 mg BID
n=1593 participants at risk
lorcaserin 10 mg BID tablets
|
Year 1 - Matching Placebo BID
n=1584 participants at risk
matching placebo tablets
|
Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)
n=573 participants at risk
lorcaserin 10 mg BID tablets
|
Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)
n=283 participants at risk
lorcaserin 10 mg BID tablets, matching placebo tablets
|
Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
n=697 participants at risk
matching placebo tablets
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
109/1593 • Number of events 118 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
5.4%
85/1584 • Number of events 100 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
5.9%
34/573 • Number of events 38 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
3.2%
9/283 • Number of events 10 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.3%
30/697 • Number of events 31 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Dizziness
|
8.2%
130/1593 • Number of events 149 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
3.8%
60/1584 • Number of events 69 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
1.7%
10/573 • Number of events 11 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
2.8%
8/283 • Number of events 8 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
2.4%
17/697 • Number of events 17 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.4%
70/1593 • Number of events 79 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.7%
75/1584 • Number of events 87 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
6.6%
38/573 • Number of events 44 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
6.0%
17/283 • Number of events 18 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
6.2%
43/697 • Number of events 51 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
99/1593 • Number of events 114 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
5.6%
89/1584 • Number of events 93 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
5.9%
34/573 • Number of events 39 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
5.7%
16/283 • Number of events 19 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.3%
30/697 • Number of events 33 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
106/1593 • Number of events 116 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.0%
64/1584 • Number of events 72 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
2.4%
14/573 • Number of events 16 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
2.8%
8/283 • Number of events 9 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
1.6%
11/697 • Number of events 11 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
83/1593 • Number of events 84 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
2.3%
37/1584 • Number of events 37 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.17%
1/573 • Number of events 1 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
1.1%
3/283 • Number of events 3 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
0.29%
2/697 • Number of events 2 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
General disorders
Fatigue
|
6.0%
95/1593 • Number of events 108 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
3.0%
48/1584 • Number of events 51 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
2.6%
15/573 • Number of events 15 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
1.8%
5/283 • Number of events 6 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
2.3%
16/697 • Number of events 17 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Gastroenteritis viral
|
5.0%
79/1593 • Number of events 87 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.0%
64/1584 • Number of events 67 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
3.1%
18/573 • Number of events 18 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.9%
14/283 • Number of events 14 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
3.0%
21/697 • Number of events 25 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Nervous system disorders
Headache
|
18.0%
287/1593 • Number of events 388 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
11.0%
175/1584 • Number of events 211 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
7.2%
41/573 • Number of events 49 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
6.4%
18/283 • Number of events 25 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.3%
30/697 • Number of events 42 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Influenza
|
4.6%
73/1593 • Number of events 81 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.4%
69/1584 • Number of events 72 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
6.6%
38/573 • Number of events 39 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.9%
14/283 • Number of events 15 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
6.0%
42/697 • Number of events 44 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Nasopharyngitis
|
13.4%
213/1593 • Number of events 249 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
12.0%
190/1584 • Number of events 223 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
16.4%
94/573 • Number of events 114 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
13.8%
39/283 • Number of events 45 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
12.6%
88/697 • Number of events 103 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
119/1593 • Number of events 141 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
5.4%
85/1584 • Number of events 90 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
3.5%
20/573 • Number of events 20 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
3.2%
9/283 • Number of events 9 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.2%
29/697 • Number of events 32 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Sinusitis
|
7.2%
114/1593 • Number of events 139 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
8.2%
130/1584 • Number of events 152 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
8.6%
49/573 • Number of events 62 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
10.6%
30/283 • Number of events 33 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
6.9%
48/697 • Number of events 59 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.8%
235/1593 • Number of events 280 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
11.9%
189/1584 • Number of events 216 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
14.5%
83/573 • Number of events 100 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
11.0%
31/283 • Number of events 41 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
16.1%
112/697 • Number of events 131 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
106/1593 • Number of events 132 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
6.1%
96/1584 • Number of events 112 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
7.2%
41/573 • Number of events 48 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
4.9%
14/283 • Number of events 15 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
5.0%
35/697 • Number of events 37 • Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study results are only allowed with prior written consent from Arena Pharmaceuticals, Inc.
- Publication restrictions are in place
Restriction type: OTHER