| Symptoms |
No of patients |
Grade |
SAE |
Start and end time (study week) |
Outcome |
Relation |
Unex-pected
AE |
AE leading to withdrawal |
| Subfebrile temperature |
1 |
Mild |
No |
1-52 |
Resolved |
Yes |
No |
No |
| Weakness |
1 |
Moderate |
No |
8-60 |
Improved |
Yes |
No |
No |
| Headache |
1 |
Moderate |
No |
8-60 |
Improved |
Yes |
No |
No |
| Anxiety |
1 |
Moderate |
No |
8-52 |
Resolved |
Yes |
No |
No |
| Hair loss |
1 |
Mild |
No |
14-52 |
Resolved |
Yes |
No |
No |
| Rash |
1 |
Mild |
No |
19-20 |
Resolved |
Yes |
No |
No |
| Eczema |
1 |
Mild |
No |
Pre study– 72 |
Persistent |
Yes |
No |
No |
Chr.
headache |
1 |
Mild |
No |
36-72 |
Improved |
Yes |
No |
No |
| Heartburn |
1 |
Mild |
No |
8-72 |
Improved |
Yes |
No |
No |
| Barrett esophagus |
1 |
Moderate |
No |
12-12 |
Resolved, but residual effects persist |
Yes |
No |
No |
| Arterial hypertension |
1 |
Moderate |
No |
No data |
Persistent |
Yes |
No |
No |
| Blood in stool |
1 |
Mild |
No |
32-32 |
Resolved |
Yes |
No |
No |
| Prostate hyperplasia |
1 |
Mild |
No |
40-72 |
Persistent |
Yes |
No |
No |
| Rash |
1 |
Mild |
No |
1-6 |
Resolved |
Yes |
No |
No |
| Dryness of mouth |
1 |
Mild |
No |
6-20 |
Resolved |
Yes |
No |
No |
| Stomach ache |
1 |
Mild |
No |
Baseline-2 |
Resolved |
Yes |
Yes |
No |
| Urine tract infection |
1 |
Mild |
No |
24-24 |
Resolved |
No |
Yes |
No |
|