Safer than vitamins. Frequency Threshold for Re

Safer than vitamins.

Frequency Threshold for Reporting Other Adverse Events 3%
Pro 140 Weekly for 1 Week Placebo Weekly for 1 Week Part 2 PRO 140 Open Label for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total 2/25 (8.00%) 2/27 (7.41%) 34/52 (65.38%)
Gastrointestinal disorders
Diarrhoea † 1 0/25 (0.00%) 0/27 (0.00%) 6/52 (11.54%)
Abdominal pain † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Nausea † 1 1/25 (4.00%) 0/27 (0.00%) 2/52 (3.85%)
General disorders
Fatigue * 1 1/25 (4.00%) 0/27 (0.00%) 3/52 (5.77%)
Injection site haemorrhage * 1 0/25 (0.00%) 1/27 (3.70%) 5/52 (9.62%)
Injection site pain † 1 0/25 (0.00%) 1/27 (3.70%) 2/52 (3.85%)
Injection site bruising † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Oedema peripheral † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Infections and infestations
Acute sinusitis † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Nasopharyngitis † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Pneumonia † 1 0/25 (0.00%) 0/27 (0.00%) 3/52 (5.77%)
Upper respiratory tract infection † 1 0/25 (0.00%) 0/27 (0.00%) 3/52 (5.77%)
Urinary tract infection † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Injury, poisoning and procedural complications
Contusion † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Laceration † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Metabolism and nutrition disorders
Dehydration † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Malnutrition † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1 0/25 (0.00%) 0/27 (0.00%) 5/52 (9.62%)
Back pain † 1 0/25 (0.00%) 0/27 (0.00%) 3/52 (5.77%)
Neck pain † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Nervous system disorders
Dizziness † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Headache † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Psychiatric disorders
Insomnia † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
Skin and subcutaneous tissue disorders
Rash † 1 0/25 (0.00%) 0/27 (0.00%) 3/52 (5.77%)
Vascular disorders
Hypotension † 1 0/25 (0.00%) 0/27 (0.00%) 2/52 (3.85%)
1 Term from vocabulary, MedDRA (17.0)
† Indicates events were collected by systematic assessment
* Indicates events were collected by non-systematic assessment
Limitations and CaveatsGo to sections
[Not Specified]