Time Frame |
Baseline up to 6 weeks after the last dose of study drug (Week 54)
|
Adverse Event Reporting Description |
As-treated population included all randomized participants who actually received any study treatment.
|
|
Arm/Group Title
|
High-Dose Ataluren
|
Low-Dose Ataluren
|
Placebo
|
Arm/Group Description |
Participants received ataluren susp...
|
Participants received ataluren susp...
|
Participants received placebo match...
|
Arm/Group Description |
Participants received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for 48 weeks.
|
Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
|
Participants received placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
|
|
|
High-Dose Ataluren
|
Low-Dose Ataluren
|
Placebo
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
--/--
|
|
--/--
|
|
|
|
High-Dose Ataluren
|
Low-Dose Ataluren
|
Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
2/60 (3.33%)
|
|
2/57 (3.51%)
|
|
3/57 (5.26%)
|
|
Cardiac disorders |
|
|
|
Supraventricular tachycardia |
1/60 (1.67%)
|
|
0/57 (0.00%)
|
|
0/57 (0.00%)
|
|
Gastrointestinal disorders |
|
|
|
Abdominal pain |
0/60 (0.00%)
|
|
0/57 (0.00%)
|
|
1/57 (1.75%)
|
|
Infections and infestations |
|
|
|
Appendicitis |
0/60 (0.00%)
|
|
1/57 (1.75%)
|
|
0/57 (0.00%)
|
|
Influenza |
0/60 (0.00%)
|
|
0/57 (0.00%)
|
|
1/57 (1.75%)
|
|
Varicella |
0/60 (0.00%)
|
|
0/57 (0.00%)
|
|
1/57 (1.75%)
|
|
Injury, poisoning and procedural complications |
|
|
|
Femur fracture |
0/60 (0.00%)
|
|
0/57 (0.00%)
|
|
1/57 (1.75%)
|
|
Lower limb fracture |
1/60 (1.67%)
|
|
0/57 (0.00%)
|
|
0/57 (0.00%)
|
|
Metabolism and nutrition disorders |
|
|
|
Dehydration |
0/60 (0.00%)
|
|
1/57 (1.75%)
|
|
0/57 (0.00%)
|
|
Nervous system disorders |
|
|
|
Grand mal convulsion |
0/60 (0.00%)
|
|
0/57 (0.00%)
|
|
1/57 (1.75%)
|
|
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 9.1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
High-Dose Ataluren
|
Low-Dose Ataluren
|
Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
58/60 (96.67%)
|
|
56/57 (98.25%)
|
|
57/57 (100.00%)
|
|
Blood and lymphatic system disorders |
|
|
|
Lymphadenopathy |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
2/57 (3.51%)
|
2 |
Microcytic anaemia |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
Arrhythmia |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Dilatation ventricular |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Left ventricular hypertrophy |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Palpitations |
2/60 (3.33%)
|
2 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Sinus bradycardia |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Supraventricular extrasystoles |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Supraventricular tachycardia |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Congenital, familial and genetic disorders |
|
|
|
Kidney malformation |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Macroglossia |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Ear and labyrinth disorders |
|
|
|
Ear congestion |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
0/57 (0.00%)
|
0 |
Ear pain |
1/60 (1.67%)
|
1 |
2/57 (3.51%)
|
3 |
3/57 (5.26%)
|
3 |
Motion sickness |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Tinnitus |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
Tympanic membrane hyperaemia |
2/60 (3.33%)
|
2 |
2/57 (3.51%)
|
5 |
1/57 (1.75%)
|
1 |
Tympanic membrane perforation |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
Goitre |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Eye disorders |
|
|
|
Abnormal sensation in eye |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Cataract |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Conjunctivitis |
3/60 (5.00%)
|
3 |
2/57 (3.51%)
|
2 |
1/57 (1.75%)
|
1 |
Conjunctivitis allergic |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Eye pain |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Eye pruritus |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Eye swelling |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Eyelid cyst |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Hypermetropia |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Ocular hyperaemia |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Vision blurred |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Visual impairment |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
Abdominal discomfort |
2/60 (3.33%)
|
2 |
0/57 (0.00%)
|
0 |
4/57 (7.02%)
|
4 |
Abdominal pain |
12/60 (20.00%)
|
23 |
8/57 (14.04%)
|
8 |
4/57 (7.02%)
|
10 |
Abdominal pain lower |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Abdominal pain upper |
13/60 (21.67%)
|
32 |
9/57 (15.79%)
|
18 |
9/57 (15.79%)
|
13 |
Abdominal tenderness |
2/60 (3.33%)
|
2 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Aerophagia |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
2/57 (3.51%)
|
2 |
Anal pruritus |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Aphthous stomatitis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Chapped lips |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Constipation |
4/60 (6.67%)
|
6 |
2/57 (3.51%)
|
3 |
2/57 (3.51%)
|
2 |
Diarrhoea |
18/60 (30.00%)
|
39 |
11/57 (19.30%)
|
15 |
15/57 (26.32%)
|
20 |
Dyspepsia |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Dysphagia |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Enteritis |
2/60 (3.33%)
|
2 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Faecal incontinence |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Flatulence |
10/60 (16.67%)
|
10 |
5/57 (8.77%)
|
5 |
4/57 (7.02%)
|
4 |
Frequent bowel movements |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Gastritis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Gastrooesophageal reflux disease |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Gingival bleeding |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Gingivitis |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Haematemesis |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Ileus |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Lip dry |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Mouth ulceration |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Nausea |
10/60 (16.67%)
|
16 |
8/57 (14.04%)
|
16 |
7/57 (12.28%)
|
9 |
Oral pain |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Reflux oesophagitis |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Regurgitation |
1/60 (1.67%)
|
1 |
2/57 (3.51%)
|
4 |
0/57 (0.00%)
|
0 |
Stomach discomfort |
5/60 (8.33%)
|
7 |
4/57 (7.02%)
|
4 |
0/57 (0.00%)
|
0 |
Tooth disorder |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Tooth impacted |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Tooth loss |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Toothache |
1/60 (1.67%)
|
1 |
2/57 (3.51%)
|
2 |
1/57 (1.75%)
|
1 |
Vomiting |
28/60 (46.67%)
|
72 |
33/57 (57.89%)
|
88 |
22/57 (38.60%)
|
48 |
General disorders |
|
|
|
Adhesion |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Asthenia |
4/60 (6.67%)
|
5 |
3/57 (5.26%)
|
4 |
2/57 (3.51%)
|
2 |
Disease progression |
5/60 (8.33%)
|
5 |
4/57 (7.02%)
|
4 |
6/57 (10.53%)
|
6 |
Energy increased |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Fatigue |
6/60 (10.00%)
|
6 |
2/57 (3.51%)
|
2 |
2/57 (3.51%)
|
3 |
Feeling abnormal |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Feeling hot |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Gait disturbance |
4/60 (6.67%)
|
4 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Ill-defined disorder |
1/60 (1.67%)
|
4 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Malaise |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
1/57 (1.75%)
|
1 |
Pain |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Pyrexia |
8/60 (13.33%)
|
10 |
14/57 (24.56%)
|
21 |
12/57 (21.05%)
|
14 |
Thirst |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Immune system disorders |
|
|
|
Drug hypersensitivity |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Hypersensitivity |
1/60 (1.67%)
|
2 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Seasonal allergy |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
4/57 (7.02%)
|
4 |
Infections and infestations |
|
|
|
Bronchitis |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
5/57 (8.77%)
|
5 |
Catheter site infection |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Croup infectious |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Cystitis |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Ear infection |
4/60 (6.67%)
|
5 |
3/57 (5.26%)
|
4 |
4/57 (7.02%)
|
4 |
Eczema infected |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Enterobiasis |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Eyelid infection |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Fungal infection |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Gastroenteritis |
6/60 (10.00%)
|
7 |
10/57 (17.54%)
|
10 |
4/57 (7.02%)
|
7 |
Gastroenteritis viral |
3/60 (5.00%)
|
3 |
4/57 (7.02%)
|
4 |
3/57 (5.26%)
|
4 |
Genital candidiasis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Herpes zoster |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
Hordeolum |
2/60 (3.33%)
|
4 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Influenza |
7/60 (11.67%)
|
9 |
6/57 (10.53%)
|
8 |
8/57 (14.04%)
|
9 |
Infusion site infection |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Lice infestation |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Localised infection |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Lower respiratory tract infection |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Measles |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Molluscum contagiosum |
1/60 (1.67%)
|
1 |
2/57 (3.51%)
|
3 |
0/57 (0.00%)
|
0 |
Nasopharyngitis |
10/60 (16.67%)
|
15 |
13/57 (22.81%)
|
22 |
13/57 (22.81%)
|
17 |
Oral candidiasis |
1/60 (1.67%)
|
2 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Oral herpes |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Otitis externa |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Otitis media |
2/60 (3.33%)
|
2 |
0/57 (0.00%)
|
0 |
4/57 (7.02%)
|
4 |
Paronychia |
0/60 (0.00%)
|
0 |
4/57 (7.02%)
|
4 |
1/57 (1.75%)
|
1 |
Pharyngitis |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
0/57 (0.00%)
|
0 |
Pharyngitis streptococcal |
2/60 (3.33%)
|
3 |
1/57 (1.75%)
|
3 |
3/57 (5.26%)
|
3 |
Pharyngotonsillitis |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Pneumonia |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Post procedural infection |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Postoperative wound infection |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Respiratory tract infection |
1/60 (1.67%)
|
3 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Rhinitis |
3/60 (5.00%)
|
4 |
7/57 (12.28%)
|
11 |
2/57 (3.51%)
|
2 |
Roseola |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Scarlet fever |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Sinusitis |
2/60 (3.33%)
|
2 |
1/57 (1.75%)
|
1 |
4/57 (7.02%)
|
7 |
Skin infection |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Tinea capitis |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Tinea infection |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Tinea pedis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
4 |
Tonsillitis |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
0/57 (0.00%)
|
0 |
Upper respiratory tract infection |
12/60 (20.00%)
|
18 |
9/57 (15.79%)
|
16 |
12/57 (21.05%)
|
17 |
Urinary tract infection |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Varicella |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
1/57 (1.75%)
|
1 |
Viral infection |
3/60 (5.00%)
|
4 |
3/57 (5.26%)
|
3 |
1/57 (1.75%)
|
1 |
Viral pharyngitis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Viral upper respiratory tract infection |
2/60 (3.33%)
|
2 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
Accident |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Accidental overdose |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Arthropod bite |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
2 |
3/57 (5.26%)
|
3 |
Arthropod sting |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Back injury |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Chillblains |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
2 |
0/57 (0.00%)
|
0 |
Contusion |
8/60 (13.33%)
|
9 |
8/57 (14.04%)
|
10 |
4/57 (7.02%)
|
4 |
Excoriation |
3/60 (5.00%)
|
3 |
0/57 (0.00%)
|
0 |
4/57 (7.02%)
|
6 |
Eye injury |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Face injury |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Fall |
7/60 (11.67%)
|
14 |
11/57 (19.30%)
|
15 |
7/57 (12.28%)
|
7 |
Femur fracture |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
2 |
Foot fracture |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Hand fracture |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Head injury |
2/60 (3.33%)
|
3 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Humerus fracture |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Iliotibial band syndrome |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Incision site erythema |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Joint injury |
0/60 (0.00%)
|
0 |
5/57 (8.77%)
|
5 |
1/57 (1.75%)
|
1 |
Joint sprain |
4/60 (6.67%)
|
4 |
4/57 (7.02%)
|
4 |
1/57 (1.75%)
|
1 |
Laceration |
1/60 (1.67%)
|
2 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Limb injury |
0/60 (0.00%)
|
0 |
5/57 (8.77%)
|
6 |
1/57 (1.75%)
|
1 |
Lower limb fracture |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Lumbar vertebral fracture |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Muscle strain |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Post procedural discomfort |
3/60 (5.00%)
|
3 |
6/57 (10.53%)
|
8 |
0/57 (0.00%)
|
0 |
Post procedural haematoma |
4/60 (6.67%)
|
4 |
3/57 (5.26%)
|
3 |
2/57 (3.51%)
|
2 |
Post procedural swelling |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Procedural pain |
11/60 (18.33%)
|
17 |
10/57 (17.54%)
|
13 |
10/57 (17.54%)
|
14 |
Scratch |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Skin laceration |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
3/57 (5.26%)
|
3 |
Spinal compression fracture |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
2 |
0/57 (0.00%)
|
0 |
Sunburn |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Suture rupture |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Thermal burn |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Tibia fracture |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
Tooth fracture |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Tooth injury |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Traumatic haematoma |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Wound |
2/60 (3.33%)
|
2 |
0/57 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
Wound dehiscence |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Wrist fracture |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Investigations |
|
|
|
Blood aldosterone increased |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Blood alkaline phosphatase increased |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Blood bicarbonate abnormal |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Blood bicarbonate decreased |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Blood calcium increased |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Blood magnesium increased |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Blood pressure increased |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Immunoglobulins decreased |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Renin increased |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Thyroxine free increased |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Thyroxine increased |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Urine colour abnormal |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
3 |
Weight decreased |
5/60 (8.33%)
|
5 |
6/57 (10.53%)
|
6 |
1/57 (1.75%)
|
1 |
Weight increased |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Metabolism and nutrition disorders |
|
|
|
Decreased appetite |
5/60 (8.33%)
|
6 |
5/57 (8.77%)
|
6 |
2/57 (3.51%)
|
2 |
Dehydration |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Hyperuricaemia |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Iron deficiency |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
7/60 (11.67%)
|
9 |
2/57 (3.51%)
|
2 |
2/57 (3.51%)
|
2 |
Back pain |
6/60 (10.00%)
|
15 |
9/57 (15.79%)
|
9 |
5/57 (8.77%)
|
10 |
Coccydynia |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Groin pain |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
2/57 (3.51%)
|
3 |
Joint contracture |
3/60 (5.00%)
|
3 |
3/57 (5.26%)
|
3 |
0/57 (0.00%)
|
0 |
Joint swelling |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Lordosis |
2/60 (3.33%)
|
2 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Muscle contracture |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Muscle spasms |
1/60 (1.67%)
|
1 |
3/57 (5.26%)
|
4 |
5/57 (8.77%)
|
8 |
Muscle tightness |
1/60 (1.67%)
|
1 |
2/57 (3.51%)
|
2 |
1/57 (1.75%)
|
1 |
Muscular weakness |
5/60 (8.33%)
|
5 |
3/57 (5.26%)
|
3 |
2/57 (3.51%)
|
2 |
Musculoskeletal chest pain |
1/60 (1.67%)
|
1 |
2/57 (3.51%)
|
4 |
1/57 (1.75%)
|
1 |
Musculoskeletal pain |
2/60 (3.33%)
|
2 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Myalgia |
2/60 (3.33%)
|
2 |
3/57 (5.26%)
|
3 |
2/57 (3.51%)
|
2 |
Neck pain |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Osteoporosis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Pain in extremity |
8/60 (13.33%)
|
16 |
8/57 (14.04%)
|
12 |
6/57 (10.53%)
|
7 |
Scoliosis |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Tendinous contracture |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Tendon disorder |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Trendelenburg's symptom |
1/60 (1.67%)
|
2 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Melanocytic naevus |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Skin papilloma |
1/60 (1.67%)
|
1 |
2/57 (3.51%)
|
3 |
1/57 (1.75%)
|
1 |
Nervous system disorders |
|
|
|
Areflexia |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Convulsion |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Dizziness |
3/60 (5.00%)
|
3 |
3/57 (5.26%)
|
4 |
4/57 (7.02%)
|
5 |
Headache |
16/60 (26.67%)
|
85 |
23/57 (40.35%)
|
69 |
14/57 (24.56%)
|
25 |
Hypertonia |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Hypotonia |
2/60 (3.33%)
|
2 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Lethargy |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Migraine |
1/60 (1.67%)
|
2 |
2/57 (3.51%)
|
4 |
0/57 (0.00%)
|
0 |
Psychomotor hyperactivity |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Sinus headache |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Syncope |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Unresponsive to stimuli |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
Abnormal behaviour |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Aggression |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Agitation |
1/60 (1.67%)
|
3 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Anger |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Anxiety |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
1/57 (1.75%)
|
2 |
Attention deficit/hyperactivity disorder |
3/60 (5.00%)
|
3 |
2/57 (3.51%)
|
2 |
0/57 (0.00%)
|
0 |
Depression |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Emotional disorder |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Encopresis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Initial insomnia |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Insomnia |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
2/57 (3.51%)
|
3 |
Mood swings |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Obsessive-compulsive disorder |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Oppositional defiant disorder |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Sleep disorder |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Somnambulism |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Stress |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Tic |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
2 |
Renal and urinary disorders |
|
|
|
Dysuria |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Enuresis |
3/60 (5.00%)
|
4 |
4/57 (7.02%)
|
4 |
0/57 (0.00%)
|
0 |
Incontinence |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Myoglobinuria |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
3 |
0/57 (0.00%)
|
0 |
Pollakiuria |
2/60 (3.33%)
|
2 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Pyelocaliectasis |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Renal cyst |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Residual urine |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Strangury |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Ureteric dilatation |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Urinary incontinence |
2/60 (3.33%)
|
2 |
2/57 (3.51%)
|
2 |
2/57 (3.51%)
|
2 |
Urine abnormality |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
Balanitis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Genital erythema |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Pruritus genital |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Testicular pain |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Asthma |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Bronchial hyperreactivity |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Cough |
15/60 (25.00%)
|
27 |
9/57 (15.79%)
|
14 |
13/57 (22.81%)
|
19 |
Dyspnoea |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Epistaxis |
3/60 (5.00%)
|
7 |
3/57 (5.26%)
|
6 |
1/57 (1.75%)
|
1 |
Nasal congestion |
6/60 (10.00%)
|
8 |
5/57 (8.77%)
|
8 |
5/57 (8.77%)
|
9 |
Nasal discomfort |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Oropharyngeal pain |
4/60 (6.67%)
|
7 |
6/57 (10.53%)
|
7 |
4/57 (7.02%)
|
7 |
Productive cough |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Pulmonary congestion |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Rhinitis allergic |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
3 |
0/57 (0.00%)
|
0 |
Rhinorrhoea |
1/60 (1.67%)
|
1 |
4/57 (7.02%)
|
7 |
6/57 (10.53%)
|
8 |
Sinus congestion |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
2 |
Sneezing |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Throat irritation |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
2 |
0/57 (0.00%)
|
0 |
Upper respiratory tract congestion |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
Wheezing |
2/60 (3.33%)
|
4 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Skin and subcutaneous tissue disorders |
|
|
|
Acne |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Decubitus ulcer |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Dermatitis allergic |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Dermatitis contact |
1/60 (1.67%)
|
1 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Dry skin |
0/60 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
3/57 (5.26%)
|
3 |
Ecchymosis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Eczema |
2/60 (3.33%)
|
3 |
1/57 (1.75%)
|
1 |
2/57 (3.51%)
|
2 |
Erythema |
1/60 (1.67%)
|
1 |
3/57 (5.26%)
|
4 |
0/57 (0.00%)
|
0 |
Exfoliative rash |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Heat rash |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Hyperhidrosis |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Hyperkeratosis |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Ingrowing nail |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Keratosis pilaris |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Nail disorder |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Night sweats |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Pruritus |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
2/57 (3.51%)
|
2 |
Rash |
8/60 (13.33%)
|
8 |
6/57 (10.53%)
|
7 |
5/57 (8.77%)
|
6 |
Rash erythematous |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Rash follicular |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Rash generalised |
0/60 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Rash maculo-papular |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Rash papular |
2/60 (3.33%)
|
2 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Scar |
5/60 (8.33%)
|
9 |
4/57 (7.02%)
|
8 |
4/57 (7.02%)
|
7 |
Skin discolouration |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Skin irritation |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Skin lesion |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Urticaria |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
1/57 (1.75%)
|
1 |
Surgical and medical procedures |
|
|
|
Endodontic procedure |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Tooth extraction |
0/60 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
0/57 (0.00%)
|
0 |
Vascular disorders |
|
|
|
Flushing |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
1/57 (1.75%)
|
1 |
Hypertension |
0/60 (0.00%)
|
0 |
4/57 (7.02%)
|
6 |
1/57 (1.75%)
|
1 |
Hypotension |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Pallor |
1/60 (1.67%)
|
1 |
0/57 (0.00%)
|
0 |
0/57 (0.00%)
|
0 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 9.1
|