Trial Outcomes & Findings for A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches (NCT NCT00257010)
NCT ID: NCT00257010
Last Updated: 2014-02-21
Results Overview
Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
447 participants
Primary outcome timeframe
2 hours and 24 hours post-dose
Results posted on
2014-02-21
Participant Flow
This study was conducted at 55 sites in the United States.
Of the 447 participants enrolled, 420 participants took at least one dose of study drug according to the Headache Record and were included in the analysis.
Participant milestones
| Measure |
Almotriptan Malate
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Overall Study
STARTED
|
447
|
|
Overall Study
COMPLETED
|
319
|
|
Overall Study
NOT COMPLETED
|
128
|
Reasons for withdrawal
| Measure |
Almotriptan Malate
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
11
|
|
Overall Study
Lost to Follow-up
|
53
|
|
Overall Study
Withdrawal by Subject
|
34
|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
various
|
11
|
|
Overall Study
no headache reported
|
9
|
Baseline Characteristics
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Baseline characteristics by cohort
| Measure |
Almotriptan Malate
n=447 Participants
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Age, Continuous
|
14.4 years
STANDARD_DEVIATION 1.63 • n=93 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 hours and 24 hours post-dosePopulation: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.
Outcome measures
| Measure |
Almotriptan Malate
n=7941 headaches
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Number of Pain Free Headaches at 2 and 24 Hours Post-Dose
Headaches Pain Free at 2 hours
|
3218 Number of headaches
|
|
Number of Pain Free Headaches at 2 and 24 Hours Post-Dose
Headaches Pain Free at 24 hours
|
5236 Number of headaches
|
|
Number of Pain Free Headaches at 2 and 24 Hours Post-Dose
Headaches Sustained Pain Free at 24 hours
|
3048 Number of headaches
|
SECONDARY outcome
Timeframe: 2 hours and 24 hours post-dosePopulation: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
Headache pain relief is defined as a decrease in baseline pain intensity from either severe or moderate intensity to mild or no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain relief is defined as pain relief at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.
Outcome measures
| Measure |
Almotriptan Malate
n=6099 headaches
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose
Headaches Sustained Pain Relief at 24 hours
|
3384 Number of headaches
|
|
Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose
Headaches Pain Relief at 2 hours
|
3765 Number of headaches
|
|
Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose
Headaches Pain Relief at 24 hours
|
4182 Number of headaches
|
SECONDARY outcome
Timeframe: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dosePopulation: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.
Outcome measures
| Measure |
Almotriptan Malate
n=8052 headaches
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Number of Headaches With Photophobia
At baseline
|
6164 Number of headaches with photophobia
|
|
Number of Headaches With Photophobia
At 2 hours
|
3150 Number of headaches with photophobia
|
|
Number of Headaches With Photophobia
At 24 hours
|
936 Number of headaches with photophobia
|
SECONDARY outcome
Timeframe: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dosePopulation: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.
Outcome measures
| Measure |
Almotriptan Malate
n=8052 headaches
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Number of Headaches With Phonophobia
At baseline
|
5783 Number of headaches with phonophobia
|
|
Number of Headaches With Phonophobia
At 2 hours
|
2847 Number of headaches with phonophobia
|
|
Number of Headaches With Phonophobia
At 24 hours
|
805 Number of headaches with phonophobia
|
SECONDARY outcome
Timeframe: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dosePopulation: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
Occurrence and intensity of nausea post-dose of study medication. Nausea is a feeling of sickness characterized by gastrointestinal distress and an urge to vomit.
Outcome measures
| Measure |
Almotriptan Malate
n=8052 headaches
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Number of Headaches With Nausea
At baseline
|
3262 Number of headaches with nausea
|
|
Number of Headaches With Nausea
At 2 hours
|
1785 Number of headaches with nausea
|
|
Number of Headaches With Nausea
At 24 hours
|
542 Number of headaches with nausea
|
SECONDARY outcome
Timeframe: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dosePopulation: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
Occurrence and intensity of vomiting post-dose of study medication. Vomiting is an act or instance of disgorging the contents of the stomach through the mouth also called emesis.
Outcome measures
| Measure |
Almotriptan Malate
n=8052 headaches
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Number of Headaches With Vomiting
At baseline
|
357 Number of headaches with vomiting
|
|
Number of Headaches With Vomiting
At 2 hours
|
258 Number of headaches with vomiting
|
|
Number of Headaches With Vomiting
At 24 hours
|
107 Number of headaches with vomiting
|
Adverse Events
Almotriptan Malate
Serious events: 8 serious events
Other events: 282 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Almotriptan Malate
n=420 participants at risk
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Cardiac disorders
Bradycardia Foetal
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Intussusception
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Appendicitis
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.24%
1/420 • 12 months
|
|
Psychiatric disorders
Major Depression
|
0.24%
1/420 • 12 months
|
Other adverse events
| Measure |
Almotriptan Malate
n=420 participants at risk
Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.71%
3/420 • 12 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.48%
2/420 • 12 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.48%
2/420 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.24%
1/420 • 12 months
|
|
Cardiac disorders
Ventricular Hypertrophy
|
0.24%
1/420 • 12 months
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
0.24%
1/420 • 12 months
|
|
Ear and labyrinth disorders
Ear Pain
|
0.48%
2/420 • 12 months
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.24%
1/420 • 12 months
|
|
Eye disorders
Eye Allergy
|
0.24%
1/420 • 12 months
|
|
Eye disorders
Eye Irritation
|
0.24%
1/420 • 12 months
|
|
Eye disorders
Hypermetropia
|
0.24%
1/420 • 12 months
|
|
Eye disorders
Myopia
|
0.24%
1/420 • 12 months
|
|
Eye disorders
Scotoma
|
0.24%
1/420 • 12 months
|
|
Eye disorders
Vision Blurred
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.48%
2/420 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.4%
10/420 • 12 months
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Chapped Lips
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
8/420 • 12 months
|
|
Gastrointestinal disorders
Dry Mouth
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.71%
3/420 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Food Poisoning
|
0.48%
2/420 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.71%
3/420 • 12 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.2%
5/420 • 12 months
|
|
Gastrointestinal disorders
Gingival Swelling
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
6.0%
25/420 • 12 months
|
|
Gastrointestinal disorders
Salivary Gland Disorder
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.95%
4/420 • 12 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Tooth Disorder
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.24%
1/420 • 12 months
|
|
Gastrointestinal disorders
Toothache
|
1.2%
5/420 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
23/420 • 12 months
|
|
General disorders
Chills
|
0.48%
2/420 • 12 months
|
|
General disorders
Fatigue
|
0.71%
3/420 • 12 months
|
|
General disorders
Influenza Like Illness
|
0.48%
2/420 • 12 months
|
|
General disorders
Malaise
|
0.24%
1/420 • 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.24%
1/420 • 12 months
|
|
General disorders
Oedema Peripheral
|
0.24%
1/420 • 12 months
|
|
General disorders
Pain
|
1.2%
5/420 • 12 months
|
|
General disorders
Pyrexia
|
3.6%
15/420 • 12 months
|
|
General disorders
Vessel Puncture Site Bruise
|
0.24%
1/420 • 12 months
|
|
Hepatobiliary disorders
Biliary Colic
|
0.24%
1/420 • 12 months
|
|
Hepatobiliary disorders
Biliary Dyskinesia
|
0.24%
1/420 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.24%
1/420 • 12 months
|
|
Immune system disorders
Drug Hypersensitivity
|
0.24%
1/420 • 12 months
|
|
Immune system disorders
Hypersensitivity
|
1.4%
6/420 • 12 months
|
|
Immune system disorders
Seasonal Allergy
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Abscess Limb
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Acute Sinusitis
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Acute Tonsillitis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Bacterial Infection
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Bronchitis
|
2.1%
9/420 • 12 months
|
|
Infections and infestations
Bronchitis Acute
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Candidiasis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Coccidioidomycosis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Conjunctivitis Infective
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Ear Infection
|
1.9%
8/420 • 12 months
|
|
Infections and infestations
Eye Infection
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Gastritis Viral
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Gastroenteritis Viral
|
3.6%
15/420 • 12 months
|
|
Infections and infestations
Gonorrhoea
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Gynaecological Chlamydia Infection
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Herpes Simplex
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Herpes Zoster
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Hordeolum
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Infectious Mononucleosis
|
0.71%
3/420 • 12 months
|
|
Infections and infestations
Influenza
|
3.3%
14/420 • 12 months
|
|
Infections and infestations
Localised Infection
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Mastitis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Nail Infection
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Nasopharyngitis
|
12.4%
52/420 • 12 months
|
|
Infections and infestations
Otitis Externa
|
0.95%
4/420 • 12 months
|
|
Infections and infestations
Otitis Media
|
1.2%
5/420 • 12 months
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Pertussis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Pharyngitis
|
2.6%
11/420 • 12 months
|
|
Infections and infestations
Pharyngitis Streptococcal
|
4.3%
18/420 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Pyelonephritis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Respiratory Tract Infection
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Rhinitis
|
0.95%
4/420 • 12 months
|
|
Infections and infestations
Sinusitis
|
6.9%
29/420 • 12 months
|
|
Infections and infestations
Skin Infection
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Staphylococcal Infection
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Subcutaneous Abscess
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Tinea Infection
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Tonsillitis
|
0.71%
3/420 • 12 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.7%
28/420 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
5/420 • 12 months
|
|
Infections and infestations
Vaginal Candidiasis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Varicella
|
0.48%
2/420 • 12 months
|
|
Infections and infestations
Viraemia
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Viral Infection
|
3.1%
13/420 • 12 months
|
|
Infections and infestations
Viral Rhinitis
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
1.9%
8/420 • 12 months
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.24%
1/420 • 12 months
|
|
Infections and infestations
Vulvovaginitis Trichomonal
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Chemical Eye Injury
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Concussion
|
1.7%
7/420 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
6/420 • 12 months
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.48%
2/420 • 12 months
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Foreign Body Trauma
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.71%
3/420 • 12 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.48%
2/420 • 12 months
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
2.9%
12/420 • 12 months
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.71%
3/420 • 12 months
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.95%
4/420 • 12 months
|
|
Injury, poisoning and procedural complications
Medical Device Pain
|
0.48%
2/420 • 12 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.48%
2/420 • 12 months
|
|
Injury, poisoning and procedural complications
Periorbital Haematoma
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.48%
2/420 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.71%
3/420 • 12 months
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.24%
1/420 • 12 months
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.71%
3/420 • 12 months
|
|
Investigations
Alanine Aminotransferase Increased
|
0.24%
1/420 • 12 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.24%
1/420 • 12 months
|
|
Investigations
Blood Glucose Increased
|
0.48%
2/420 • 12 months
|
|
Investigations
Blood Triglycerides Increased
|
0.24%
1/420 • 12 months
|
|
Investigations
Blood Urine Present
|
0.24%
1/420 • 12 months
|
|
Investigations
Electrocardiogram Pr Prolongation
|
0.24%
1/420 • 12 months
|
|
Investigations
Electrocardiogram QRS Complex Prolonged
|
0.24%
1/420 • 12 months
|
|
Investigations
Epstein-Barr Virus Test Positive
|
0.24%
1/420 • 12 months
|
|
Investigations
Glucose Urine Present
|
0.24%
1/420 • 12 months
|
|
Investigations
Haematocrit Decreased
|
0.24%
1/420 • 12 months
|
|
Investigations
Haemoglobin Decreased
|
0.24%
1/420 • 12 months
|
|
Investigations
Lymph Nodes Scan Abnormal
|
0.24%
1/420 • 12 months
|
|
Investigations
Neutrophil Count Increased
|
0.24%
1/420 • 12 months
|
|
Investigations
Protein Urine
|
0.48%
2/420 • 12 months
|
|
Investigations
Protein Urine Present
|
0.48%
2/420 • 12 months
|
|
Investigations
Red Blood Cell Count Decreased
|
0.24%
1/420 • 12 months
|
|
Investigations
Red Blood Cells Urine
|
0.24%
1/420 • 12 months
|
|
Investigations
Spleen Palpable
|
0.24%
1/420 • 12 months
|
|
Investigations
Weight Decreased
|
0.48%
2/420 • 12 months
|
|
Investigations
Weight Increased
|
0.48%
2/420 • 12 months
|
|
Investigations
White Blood Cell Count Increased
|
0.24%
1/420 • 12 months
|
|
Investigations
White Blood Cells Urine Positive
|
0.24%
1/420 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
2/420 • 12 months
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.24%
1/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
6/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
6/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.2%
5/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.71%
3/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.24%
1/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.24%
1/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.48%
2/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.48%
2/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.95%
4/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.24%
1/420 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular Joint Syndrome
|
0.48%
2/420 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.24%
1/420 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.24%
1/420 • 12 months
|
|
Nervous system disorders
Disturbance in Attention
|
0.24%
1/420 • 12 months
|
|
Nervous system disorders
Dizziness
|
1.9%
8/420 • 12 months
|
|
Nervous system disorders
Facial Neuralgia
|
0.24%
1/420 • 12 months
|
|
Nervous system disorders
Headache
|
1.9%
8/420 • 12 months
|
|
Nervous system disorders
Hyperreflexia
|
0.48%
2/420 • 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.48%
2/420 • 12 months
|
|
Nervous system disorders
Loss of Consciousness
|
0.24%
1/420 • 12 months
|
|
Nervous system disorders
Migraine
|
1.4%
6/420 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
0.48%
2/420 • 12 months
|
|
Nervous system disorders
Paraesthesia Oral
|
0.24%
1/420 • 12 months
|
|
Nervous system disorders
Post-Traumatic Headache
|
0.48%
2/420 • 12 months
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.24%
1/420 • 12 months
|
|
Nervous system disorders
Somnolence
|
1.4%
6/420 • 12 months
|
|
Nervous system disorders
Syncope
|
1.2%
5/420 • 12 months
|
|
Nervous system disorders
Tension Headache
|
0.24%
1/420 • 12 months
|
|
Psychiatric disorders
Affective Disorder
|
0.24%
1/420 • 12 months
|
|
Psychiatric disorders
Agitation
|
0.24%
1/420 • 12 months
|
|
Psychiatric disorders
Anxiety
|
0.24%
1/420 • 12 months
|
|
Psychiatric disorders
Attention Deficit/Hyperactivity Disorder
|
0.95%
4/420 • 12 months
|
|
Psychiatric disorders
Depression
|
0.24%
1/420 • 12 months
|
|
Psychiatric disorders
Insomnia
|
1.9%
8/420 • 12 months
|
|
Psychiatric disorders
Mood Altered
|
0.24%
1/420 • 12 months
|
|
Psychiatric disorders
Sleep Disorder
|
0.24%
1/420 • 12 months
|
|
Psychiatric disorders
Stress
|
0.24%
1/420 • 12 months
|
|
Renal and urinary disorders
Dysuria
|
0.24%
1/420 • 12 months
|
|
Renal and urinary disorders
Enuresis
|
0.24%
1/420 • 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.24%
1/420 • 12 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.7%
7/420 • 12 months
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.48%
2/420 • 12 months
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.24%
1/420 • 12 months
|
|
Reproductive system and breast disorders
Ovarian Cyst Ruptured
|
0.24%
1/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Cough
|
0.24%
1/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Respiratory Symptom
|
0.24%
1/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.48%
2/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exercise Induced
|
0.71%
3/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperactivity
|
0.24%
1/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
16/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.24%
1/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.71%
3/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.24%
1/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.0%
17/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
6.4%
27/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.24%
1/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.48%
2/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
7/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.95%
4/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.48%
2/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.24%
1/420 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
1.2%
5/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.95%
4/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
1.4%
6/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.48%
2/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
0.48%
2/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.48%
2/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Precancerous Skin Lesion
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
5/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Striae
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.24%
1/420 • 12 months
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.24%
1/420 • 12 months
|
|
Surgical and medical procedures
Tooth Extraction
|
0.24%
1/420 • 12 months
|
|
Vascular disorders
Hot Flush
|
0.24%
1/420 • 12 months
|
|
Vascular disorders
Systolic Hypertension
|
0.24%
1/420 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60