Table 3.
Total Number of Serious Adverse Events (on an intent-to-treat basis)
| Specific type of SAE | Interim (n = 99) | Standard (n = 104) | Restored (n = 27) |
|---|---|---|---|
| 1. During IM Phase of Study (First 120 Days) | |||
| Accident (car accident, assault, fall) | 1 | 1 | 0 |
| Cardio-vascular (Stroke?) | 0 | 1 | 0 |
| Gastrointestinal (hepatitis) | 1 | 0 | 0 |
| Genito-urital (kidney stones) | 0 | 1 | 0 |
| Muscular-skeletal (muscle strain) | 1 | 0 | 0 |
| Respiratory (asthma) | 2 | 0 | 0 |
| Infection (cellulitis) | 2 | 2 | 0 |
| Neurological (seizure) | 1 | 0 | 1 |
| Other (cyst, dehydration, breast cancer) | 3 | 1 | 0 |
| Total | 11 | 6 | 1 |
| 2. During Second Phase of Study (Days 121-365) | |||
| Accident (car accident, assault, fall) | 0 | 1 | 1 |
| Cardio-vascular (angina, hypertension) | 2 | 1 | 0 |
| Detoxification (benzodiazepines) | 1 | 0 | 0 |
| Gastrointestinal (constipation, hepatitis, bleeding, ulcers) | 2a | 1 | 0 |
| Genito-urital (uterine fibroids, kidney stones) | 0 | 2 | 1 |
| Muscular-skeletal (arthritis, muscle strain) | 1 | 0 | 0 |
| Respiratory (asthma, bronchitis, emphysema) | 2 | 0 | 1 |
| Infection (cellulitis, pneumonia) | 2b | 0 | 0 |
| Childbirth (and complications) | 1 | 1 | 1 |
| Neurological (seizure, stroke?) | 1 | 0 | 0 |
| Total | 12 | 6 | 4 |
Note: There was a total of 40 SAEs. Thirty-two participants reported at least one SAE, 8 of whom reported 2 SAEs each. The number of participants experiencing at least one SAE in the IM, SM and RM conditions was 19, 9 and 4, respectively.
a
Death from gastric hemorrhage at day 304 post-enrollment
b
Death from pneumonia at day 334 post-enrollment