Table 3.
Adverse events during treatment phases
| Patient | Adverse events | Treatment sequence | Treatment phase |
|---|---|---|---|
| 1 |
Fast progressing muscle weakness, back pain, weight gain (4 kg), acne, Cushing |
P/D |
Deflazacort |
| 2 |
None |
D/P |
|
| 3 |
Fast progressing muscle weakness, acne, hypertonia, fatigue, tachycardia, tremor |
P/D |
Deflazacort |
| 4 |
Fast progressing muscle weakness, mainly in head lifting |
D/P |
Deflazacort |
| 5 |
Hypertonia |
D/P |
Deflazacort |
| 6 |
Fast progressing muscle weakness, weight gain, Cushing |
P/D |
Deflazacort |
| 7 |
Weight gain |
D/P |
Deflazacort |
| 8 |
None |
D/P |
|
| 9 |
None |
P/D |
|
| 10 |
Hair loss, GIT symptoms |
P/D |
Deflazacort |
| 11 |
None |
P/D |
|
| 12 |
Weight gain (5 kg), acne, GIT symptoms |
D/P |
Deflazacort |
| 13 |
GIT symptoms |
P/D |
Placebo |
| 14 |
None |
P/D |
|
| 15 |
Fast progressing muscle weakness, head ache, sleep disturbances |
D/P |
Deflazacort |
| 16 |
None |
D/P |
|
| 17 |
None |
P/D |
|
| 18 |
GIT symptoms, acne |
D/P |
Deflazacort |
| 19 |
Weight gain |
P/D |
Placebo |
| 20 |
None |
P/D |
|
| 21 |
None |
P/D |
|
| 22 |
Fast progressing muscle weakness |
D/P |
Deflazacort |
| 23 | None | D/P |
P = placebo, D = deflazacort, GIT = gastrointestinal.